Oral single-active pantothenic acid exposure and gastrointestinal adverse events
conclusionActual non-diarrheal GI observations exist, but risk versus control is not quantified. Diarrhea verdict3102 is reused unchanged; ordinary-intake safety is not established.
boundaryNo specific advertising campaign was investigated. These data do not support claims of no adverse effects at every dose, prevention of harm by food, long-term safety or replacement of treatment.
Four separate assessment dimensions
| Effect direction and size | This is a harm question. Non-diarrheal GI observations exist, but a causal risk difference or risk ratio versus control is unverified. |
|---|---|
| Evidence certainty | Descriptive observations from one small open-label uncontrolled study; collection, overlap, attribution and comparative-risk uncertainty remain. |
| Applicability | Direct observations concern short, labeled high-dose exposure in healthy adults, once or for 14 days. No transfer to ordinary intake, long-term use, disease, children or pregnancy/lactation. |
| Safety | Caution. Observed symptoms and investigator attribution are separate; all AEs are not merged with GI events or withdrawals. |
Efficacy A–F and numerical scoring are not applicable. The original calculator was read and preserved but not run for safety. Null is not zero points or zero risk.
Useful facts when choosing a product
- The question concerns oral single-active pantothenic acid, distinct from pantethine and multi-active products.
- The directly observed tablet is described as pantothenic acid500 mg as D-calcium pantothenate, distributed by Rugby.
- Clinical acid/salt dose basis, full excipients, purity and total intake are unverified.
Chamgap Semantic Classification Code
Permanent code issued
S.pantothenic-acid-non-diarrheal-gi-single-active.oral.actual-exposed-humans-non-diarrheal-gi.non-diarrheal-gi-terms-withdrawal-reporting.uncontrolled-gi-exposure-observationsSupplements and nutraceuticals > Single-active pantothenic acid; direct preparation D-calcium pantothenate > Actual direct observations in healthy adults18–55; no generalization to deficiency, long-term/disease/childhood/pregnancy risk > Preferred-term nausea/vomiting/abdominal discomfort and GI-specific withdrawal; deduplicated composite unreported > Uncontrolled open-label direct study. Fed condition re-exposes the same eight; eligible comparative risk unverified > Oral; topical and injection excluded
Original safety-only status, efficacy N/A, null, Caution, full report and link to3102 preserved. The code identifies the intervention and claim; it never contains the evidence grade, score, or safety result.
Exact Claim Classification
These independent facets prevent evidence from different forms, routes, populations, effects, and comparators from being mixed.
| Intervention class | S · Supplement or nutraceutical |
|---|---|
| Canonical ingredient or intervention | Single-active pantothenic acid; direct preparation D-calcium pantothenate |
| Source or part used | Isolated chemical nutrient; species/part not applicable. Manufacturing source, batch and purity unreported |
| Formulation or processing | Rao oral tablets labeled 500 mg as D-calcium pantothenate; clinical acid/salt basis, release form and excipients unverified |
| Route | Oral; topical and injection excluded |
| Dose | Labeled 500/1000/2000/5000 mg once and 2000 mg/day. No reconstruction of actual acid/salt mass or total exposure |
| Duration | Single dose and 14-day repeated exposure separated; study ends on days9/22. GI onset/duration unverified |
| Population | Actual direct observations in healthy adults18–55; no generalization to deficiency, long-term/disease/childhood/pregnancy risk |
| Effect or condition | Non-diarrheal GI adverse events and interpretability of overall-GI/withdrawal reporting; diarrhea verdict3102 reused |
| Primary endpoint | Preferred-term nausea/vomiting/abdominal discomfort and GI-specific withdrawal; deduplicated composite unreported |
| Comparator | Uncontrolled open-label direct study. Fed condition re-exposes the same eight; eligible comparative risk unverified |
| Duplicate-detection key | S|pantothenic-acid-single-active|oral|actual-exposed-humans|non-diarrheal-GI-and-withdrawal-reporting|diarrhea-linked-3102|comparator-as-observed |
What the research actually shows
# Oral single-active pantothenic acid exposure and gastrointestinal adverse events
**TASK-1036 / R01-076 · Complementary safety report on non-diarrheal GI outcomes and withdrawal reporting** Input snapshot: **2026-09-17T13:00:06+09:00**. Incremental search and self-review: **2026-09-17**. The supplied snapshot is not assumed to equal the current live website.
## 1. Reader answer and present status
Actual human exposure observations include **abdominal discomfort, anorectal discomfort, discolored feces, nausea and vomiting**. The accessed evidence does **not establish how much oral single-active pantothenic acid increases GI risk versus a control, or the frequency at ordinary intake**. The central source is a small uncontrolled open-label study in healthy adults. An investigator's attribution of possible relatedness is not independent proof of causality. [S7601]
The current safety label is **Caution / 주의**. Efficacy grading and scoring are **not applicable**; numerical display fields are `null`, not zero risk or zero points. The diarrhea subclaim links to existing **3102** unchanged. This report is not a new investigation, grading or translation of that completed diarrhea verdict. [S76-REUSE3102]
The content result is `completed_with_uncertainty`, with editorial readiness `ready_with_uncertainty`. The basic safety-only semantics follow the existing 3102 example; the complete detailed record is `reports/TASK-1036.json`. Because live support for the new null efficacy display fields and detailed safety structure was not tested, technical publication status is `needs_format_mapping`. This is not a clinical hold. No clinical re-search, regrading or translation-review TODO is passed to Codex. A new site ID, slug, URL, first publication time and semantic code remain unreserved.
**Study doses are not personal dosing advice or instructions to change treatment or replace standard care.** Self-review is not independent peer review, journal certification or a guarantee of no errors.
## 2. Why this is not a full skip_duplicate
All 3,151 index records were read and screened using Korean and English pantothenic-acid/pantethine terms. All ten supplied candidate originals were also read. The primary endpoint in 3102 is diarrhea, with an explicit instruction **not to merge abdominal symptoms, nausea or a GI composite into that endpoint**. Source uncertainty, single-active identity, oral route, observed healthy-adult exposure and lack of an appropriate control overlap. The **non-diarrheal preferred terms and interpretation of overall-GI/withdrawal reporting** do not form the same completed endpoint. Accordingly, the whole task is a complementary new report; the diarrhea subclaim alone is `skip_duplicate → 3102`. [S76-REUSE3102; boundary_review.json]
| Existing record | Disposition | |---|---| | 3102 | Reuse the diarrhea safety text without alteration. Its original date, safety values and document-quality B are retained. | | 028 and 3099 | Skin/hair or inflammatory-acne efficacy, not this safety endpoint. | | 3100 and 3101 | LDL-C or fatigue efficacy, not this safety endpoint. | | 3147, 3148 and 3149 | Ulcer epithelialization, stratum-corneum hydration and TEWL efficacy. | | 3150 and 3151 | HbA1c and fasting-TG efficacy. Reuse their existing molecule, product and safety maps without reassessing those efficacy questions. | | 366 — additional index hit | Pantethine LDL/TG efficacy: different molecular intervention and endpoints. Its full original was not in this input and was not claimed read. Only the indexed identity was used to exclude it from this claim. |
The full original 3102 JSON and the complete original Korean/English `what_research` strings are preserved separately. That original has no `body_markdown`; these preserved strings are not described as an unavailable historical stand-alone full-report file. The present Korean and English `body_markdown` fields exactly match the respective full reports produced here. Reuse and restoration do not require any previous separate ZIP.
## 3. The question versus actual observations
The question concerns **GI symptoms and discontinuation after actual oral exposure to single-active pantothenic acid**. Proposed unexposed, low-exposure or active comparators in the task list are not verified study arms. Pantethine, panthenol/dexpanthenol, topical or injected preparations, multiple-active supplements, food/diet/blood-level associations, animals and mechanisms are not combined into an independent pantothenic-acid risk estimate.
Rao and colleagues' 2021 source is a single-center open-label study of 40 healthy adults aged 18–55. The single-dose component contains 32 unique people and the multiple-dose component a separate eight. The fed 5,000-mg condition re-exposes the **same eight** people from the fasted condition; it does not increase the unique total to 48. No randomized allocation, placebo, untreated arm or active control was identified. [S7601, Methods/Results]
| Observed exposure stratum | Labeled dose and administration | Table denominator | Conditions and observation window | |---|---|---:|---| | SAD 500/1,000/2,000/5,000 | Each labeled dose once orally | Eight each; 32 unique | Ordinarily at least ten hours fasting and four further hours after dosing; single-dose study completion on day 9 | | SAD 5,000 fed | Same dose on re-exposure | Same eight as SAD 5,000 | Thirty minutes after starting a high-fat meal; methods state 2–3 weeks washout, abstract states two weeks | | MD 2,000 | 2,000 mg/day for 14 days | Separate eight | Morning fasting administration; study completion on day 22 |
The mg amounts are **the publication's labeled doses**. The tablets are described as 500-mg pantothenic acid as D-calcium pantothenate, distributed by Rugby, whereas dose-table headings use calcium pantothenate. A salt/acid adjustment in the PK calculations does not automatically resolve the clinical-dose basis. Actual acid mass, salt mass and cumulative total intake were not reconstructed. Manufacturing source, purity, batch, release form and complete excipients remain unverified. Placebo excipients are **not applicable**, because there was no placebo. [S7601, Study Design/Table 1/PK Analytics]
Healthy eligibility is not a diagnosis of nondeficiency. Baseline plasma sampling did not establish a documented deficiency criterion, and dietary B5 intake was not monitored or controlled. Laboratory monitoring was not converted into a verified eGFR eligibility threshold. Supervised dosing and daily returns do not provide an individual administration log or a numerical adherence rate; neither was filled as 100%. [S7601]
Although routine medication and supplement use was prohibited, the results describe rescue paracetamol for headaches. The exposure period therefore cannot be described as completely free of all concomitant medication in every participant. Individual timing of rescue treatment, diet and other changes relative to GI symptoms is unknown. Findings are not made equivalent across deficiency treatment, diabetes, arthritis, IBD, childhood, pregnancy/lactation or significant renal/hepatic disease. [S7601, Methods/Safety]
## 4. Non-diarrheal GI observations — not a comparative-risk table
Cells show **people reporting the preferred term, n/N**, from Table 6. They are not event episodes, recurrent-event counts or person-time. The 13% figure is the publication's rounded percentage. Zeros below are explicit reported table cells, not substitutions for missing information. [S7601, Table 6, printed pages 7–8]
| Preferred term | 500 single fasted | 1,000 single fasted | 2,000 single fasted | 5,000 single fasted | 5,000 fed re-exposure | 2,000/day for 14 days | |---|---:|---:|---:|---:|---:|---:| | Abdominal discomfort | 0/8 | 0/8 | 0/8 | 1/8 (13%) | 0/8 | 1/8 (13%) | | Anorectal discomfort | 0/8 | 0/8 | 0/8 | 1/8 (13%) | 0/8 | 0/8 | | Feces discolored | 0/8 | 0/8 | 0/8 | 1/8 (13%) | 0/8 | 0/8 | | Nausea | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 (13%) | | Vomiting | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 (13%) |
**Diarrhea** was not newly extracted or adjudicated for this table; the unchanged 3102 original is linked. A separate **abdominal pain** value was not verified, and discomfort was not recoded as pain. A **deduplicated overall-GI participant count** was not supplied. Several terms may occur in one person, so the rows are not added to manufacture an overall GI frequency.
Abdominal discomfort, anorectal discomfort and discolored feces after fasted 5,000 mg appear in the investigator's list of events considered at least possibly related. The multiple-dose abdominal discomfort, nausea and vomiting are not in that list and fall under the narrative classifying the remaining events as unrelated. **Observed events and investigator attribution are retained separately**; neither causation nor its absence is established. A separate blinded adjudication committee or validated causality score was not verified. [S7601, Safety]
## 5. Ascertainment, severity and discontinuation
The publication describes safety examinations, vital signs, ECGs, laboratory tests and AE collection, with **MedDRA 21.0** preferred-term/SOC coding. It does not establish a GI-specific elicitation questionnaire, spontaneous-versus-prompted reporting distinction, diagnostic definitions for nausea/vomiting/discomfort, separate new-versus-worsened symptoms, or term-specific onset, duration and severity. Scheduled examination dates are not actual symptom-onset dates or proof of a completely observed GI time window. [S7601]
People experiencing **any AE** were 10/32 in the single-dose component (reported 31%) and 3/8 in the multiple-dose component (reported 38%). These are not GI-specific counts. The authors explicitly report no deaths, serious AEs or discontinuations due to AEs in the whole study. This **whole-study statement** is retained without creating an absent GI-specific withdrawal table or symptom-specific causal-withdrawal denominator. Completion by all participants does not demonstrate complete symptom ascertainment. [S7601]
The statement that most AEs were mild is not converted into a GI-specific severity distribution. The non-GI laboratory event described as “severe” is not conflated with “serious.” The authors report resolution of AEs by the end of the study, but individual GI recovery dates and long-term recurrence remain unknown. These distinctions preserve the reported scope; they do not certify safety. [S7601]
## 6. Calculations, denominators and comparison limits
The only calculation was a **check of descriptive percentage rounding**. Using `100 × n/N`, 1/8 equals 12.5% versus the reported 13%; 3/8 equals 37.5% versus 38%; and 10/32 equals 31.25% versus 31%. These are small-cohort descriptive proportions, not increases versus a control. Original values, recalculated values, inputs, formula and rounding convention are separated in `calculations.json`.
There is no placebo or unexposed comparison, and the dose groups are different sequential cohorts. Fasted/fed administrations involve the same people in a fixed sequence without matched event-level data or a randomized sequence. No RR, ARR/risk difference, NNH, paired comparative CI, dose-risk slope or person-time rate was calculated. Observing a zero cell after food is not evidence that food prevents an adverse effect.
PK adjusted models, geometric means and CIs are not carried over as GI risk estimates or precision. A named GI ITT/as-treated estimand, missing-data procedure, independently verified registered primary/secondary designation and multiplicity plan remain unknown. Inclusion of safety assessment in a paper does not prove that GI outcomes were registered primary endpoints. No clinically important risk difference/MCID or minimum harmful dose/duration was invented.
## 7. Other research, official material and reused records
| Evidence group | Access and use boundary | |---|---| | Rao 2021 | **The same study** already used in 3102. Publisher HTML/PDF and Table 6 images were used here only to extend the non-diarrheal extraction. Reading one paper twice does not produce independent replication. | | Historical arthritis, high-intake and UL map in 3102 | Reused from the exact current input. The 94-versus-47+46=93 participant discrepancy and missing original GI table remain unchanged. A summary of no treatment side effects is not new evidence of zero GI events. [S76-REUSE3102] | | IRCT and adjacent records in 3150/3151 | Existing source/safety maps only. Efficacy outcomes and planned dosing were not converted into observed GI numerators or denominators. [S76-REUSE3150-3151] | | NCT05701501 | An official search identified a B5 adjunctive IBD study lead. The page returned only a shell and API access failed; current recruitment, actual exposure and results were not verified. Plans are not observations. [S7602] | | NIH ODS | Current full-page access failed. Only the existing high-intake GI/UL caution preserved in 3102 was reused; no new verification of the latest full fact sheet is claimed. [S7605] | | Oregon State LPI | Used only to avoid transferring nausea/heartburn in a pantethine paragraph or a combination-product event to single-active pantothenic acid. Not independent primary GI-risk evidence. [S7603] | | FDA food-substance entry | Ingredient/food-use context. Listing is not a comparative clinical safety assessment for these doses and periods. [S7604] | | 2026 hypersensitivity lead | Full text could not be accessed; formulation, actual route, GI endpoint and denominator were not verified. The lead was not turned into a GI-risk estimate or a confirmed exclusion diagnosis. [S7606] |
An unset UL in the reused records was not translated into absence of adverse effects. Unreported, uncollected and inaccessible data are distinct reasons for uncertainty, not proof that human studies do not exist. Conversely, the existence of actual human exposure does not establish comparative risk.
## 8. Certainty and conflicting interpretation
The central study supplies actual exposure and preferred-term observations, but its small, open-label, uncontrolled and short design limits inference. A comparative causal effect requires information not provided here: an appropriate control, defined symptom collection and windows, and participant-level overlap/missingness. All-AE frequencies cannot be relabeled as GI frequencies, and an investigator's unrelatedness judgment cannot be used as proof of no risk.
The authors offer a broadly favorable interpretation of high-dose tolerability. This report does not adopt that interpretation as a demonstrated fact; it separates **reported observations from unestablished comparative risk**. Uncontrolled dietary B5 and ambiguous acid/salt dose labeling also limit attribution to an exact total exposure. Identifying those limits did not authorize rewriting the existing diarrhea verdict. [S7601; S76-REUSE3102]
**CoA Therapeutics** funded the research; employee, consulting and equity interests were disclosed. Acknowledgment of someone organizing product supply does not verify independent funding or a complete supply contract. These interests do not automatically invalidate the observations, but the study is not described as independent replication. [S7601, Conflict of Interest/Source of support]
## 9. What was searched, checked and not performed
After the duplicate-boundary review, **18 web queries** addressed the non-diarrheal GI/withdrawal gap, related registration and correction/retraction leads. Korean/English, molecular-form and GI terms were used. PubMed- and ClinicalTrials.gov-restricted queries were ordinary web searches, not exhaustive native database exports, reproducible total-hit counts or a PRISMA flow. Some results were off topic. Subscription Embase/Cochrane, complete registry histories and all unpublished data were not obtained.
Actual Rao PDF images of Table 6 and methods/dosing material were inspected. An attempt to download the original PDF into the local runtime failed due to DNS resolution, so no local publisher PDF binary or SHA is claimed. Web full-text/image access and obtaining a local original binary are different achievements. Registry API, NIH full-page and hypersensitivity-source access limits are documented.
No correction/retraction notice was identified through the specific query and accessed publisher page; this does not guarantee the absence of every subsequent notice. Completed efficacy research, scoring and translations for 71–75 were not repeated. Supplied deployment receipts were read; their live routes were not revisited or deployed here.
Self-review covered source locations, table n/N values, bilingual meaning, uncertainty status, verbatim preservation, arithmetic and field/file consistency. Counts of automated checks are not counts of independent clinical validations. The technical restoration tools neither adjudicate clinical content nor execute clinical tools.
## 10. Classification, handoff and revision conditions
The report uses `kind=S`, the existing `gut` category, `question_type=safety` and `safety_only=true`. R01, NUT and TASK identifiers are not new site categories or semantic codes. The supplied efficacy rubric and original calculator were read and preserved, but no A–F or inverted efficacy score was calculated for this safety question. Safety is **Caution**; efficacy grade/score are not applicable. No `no_human_study=true` gate was applied. Actual human exposure and the lack of a confirmed comparative risk estimate are separately structured.
Document quality is **A — a self-assessment of completeness within this request**, separate from efficacy grading, certainty about harm and the existing 3102 document-quality B. It is not independent certification. Initial `corrections=[]` is retained, while actual identifier, wording and formatting fixes made before delivery are recorded separately in `pre_submission_audit.json`.
Revision is warranted by **controlled GI results with actual denominators and a defined period; original GI-withdrawal, overlapping-event and collection-method data; verified composition/salt/active mass/total exposure; missing source text or registry results; corrections, retractions or a changed classification boundary**. These are future revision triggers, not conditions for withholding the current completed report. Updating the existing diarrhea record 3102 would require a separately specified update.
This task ends as a single completed research handoff. No server deployment, new ID reservation or automatic start of task 77 was performed.
## Source locations
- **S7601**: Rao et al., 2021. DOI **10.29011/JVM-106.100006**. [Publisher full text](https://www.gavinpublishers.com/article/view/the-pharmacokinetics-of-orally-administered-calcium-pantothenate-in-healthy-adults), [PDF](https://www.gavinpublishers.com/assets/articles_pdf/1610945487article_pdf1309862097.pdf). Methods/Safety/Statistics; Results/Safety; Table 6 printed pages 7–8; Discussion; funding. - **S7602**: [ClinicalTrials.gov NCT05701501](https://clinicaltrials.gov/study/NCT05701501). Search identity/page shell only; results inaccessible. - **S7603**: [Oregon State LPI Pantothenic Acid](https://lpi.oregonstate.edu/mic/vitamins/pantothenic-acid), Safety. Exclusion map only. - **S7604**: [FDA calcium pantothenate food-substance entry](https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?id=CALCIUMPANTOTHENATE&set=FoodSubstances). Regulatory context only. - **S7605**: [NIH ODS](https://ods.od.nih.gov/factsheets/PantothenicAcid-HealthProfessional/). Current access failed; existing 3102 S06 reused. - **S7606**: [2026 hypersensitivity search lead](https://www.mdpi.com/1999-4923/18/7/771). Full text inaccessible; not used as direct evidence. - **S76-REUSE3102**: Current ZIP `기존자료/3102.json` and `reuse/3102_what_research_original_ko.md`/`..._en.md`. Exact source/string hashes are in `reuse/original_text_provenance.json`. - **S76-REUSE3150-3151**: Current ZIP `기존자료/3150.json`, `기존자료/3151.json` and prior original `sources.json` files. Source maps reused; no efficacy reassessment.
The accompanying JSON/MD records contain every query, access level, extraction state, exact input identity and self-review result.
Why the safety label is Caution
Efficacy A–F and numerical scoring are not applicable. The original calculator was read and preserved but not run for safety. Null is not zero points or zero risk.
Counterevidence and limits. The source has zero cells and no overall AE discontinuations, but this is not proof of no GI adverse effects.
Review performed and remaining limitations
The small uncontrolled evidence does not establish a between-group GI risk or CI. GI ascertainment definitions, new-versus-worsened symptoms, term-specific severity/windows, participant overlap and a GI-specific withdrawal table are unreported or unverified. Actual acid/salt dose basis, excipients, total intake, individual adherence and long-term/special-population risks remain unverified. Registry details/API, the current NIH full page and some additional text were inaccessible. These gaps do not mean zero risk or no human studies.
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Rao et al2021; same study as existing3102 | Single-center open-label uncontrolled sequential single/multiple-dose exposure | 40 unique:32 SAD+8 MD; fed re-exposure of eight is not a new cohort | CoA Therapeutics funding; employment, consulting and equity ties disclosed | Non-diarrheal preferred terms and reporting scope of overall-GI/withdrawal outcomes | Abdominal discomfort1/8 at fasted5000 and MD; anorectal discomfort/discolored feces1/8 each at fasted5000; nausea/vomiting1/8 each in MD. No controlled risk verified | Direct descriptive exposure evidence; not comparative causal effect or independent replication |
| Historical arthritis material—3102 extraction reused | Arthritis comparison described in existing summary; no new primary review | Narrative94 versus47+46=93 retained; not a verified GI denominator | Not newly verified here; existing source record retained | Term-level GI events/withdrawal table unverified | A no-side-effects summary is not converted to zero GI events | Adjacent reused map, not new quantitative evidence |
| Adjacent diabetes study map IRCT20230702058641N2 | 3150/3151 source map reused only; no efficacy review | GI analysis denominator unverified; planned participants not used as actual GI denominator | Existing source record retained; no added GI funding/product verification | GI events/withdrawal results for this question unverified | Efficacy/protocol information not transferred to GI observations | Map of related human research, not new GI comparative evidence |
| NCT05701501 B5 adjunctive IBD registry lead | Official search identity; detailed record/results inaccessible | Actual exposure and denominator unverified | Funding and product supply unverified | GI results, withdrawals and windows unverified | Plans/recruitment text not used as observed exposure/results | No direct result available; not evidence that the study does not exist |
Receipt — 8 References
Evidence access cutoff: 2026-09-17. Each citation states its actual access level (full-text transcription, abstract, index, or other) and remaining limitations. Bibliographic checking does not certify the study results or treatment efficacy.
Technical integration by: Codex · Evidence date: 2026-09-17 · Corrections: none
Cite this safety assessment
[Chamgap] Oral single-active pantothenic acid exposure and gastrointestinal adverse events — Efficacy grade N/A · Safety caution. 8 cited sources checked. Source: https://chamgap.com/en/verdicts/gut/oral-single-pantothenic-acid-non-diarrheal-gi-safety/ · CC BY 4.0What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.