Effects of Vitamin D3 Treatment on Polycystic Ovary Symptoms: A Prospective Double-Blind Two-Phase Randomized Controlled Clinical Trial

Assessed by RV013 · Clinical Chair in Health Services Research

Assessed on 26 Feb 2026

OverallReviewer's overall integrity assessment, derived from all research questions Serious concerns

DOI 10.3390/nu17071246 (opens in new tab)

Resource ripekg:research-integrity-assessment/RIPEA5A5547915735AD6D

5 Research Questions · 2 Evidence Items

Q1.1 — Does the study have an associated retraction?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsN/A

Rationale: No rationale provided

Q1.2 — Does the study have an associated expression of concern or other relevant post-publication notice?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsN/A

Rationale: No rationale provided

Q1.3 — Do other studies by the research team highlight causes for concern?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsN/A

Rationale: No rationale provided

Q2.2 — Are there concerns relating to the timing or absence of study registration?

Automated Assessment:Assessment produced by the automated systemYes

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsN/A

Rationale: No rationale provided

Supporting Evidence (2)

Clinical Trial RegistrationSource: Clinical trial registry (e.g. ClinicalTrials.gov, ISRCTN)

Registration ID: NCT04840238

Registry: ClinicalTrials.gov

Registry Link: https://clinicaltrials.gov/study/NCT04840238 (opens in new tab)

Registration Date: 08-04-2021

Prospective:Whether the trial was registered before participant recruitment began No

Assessment Rationale:How INSPECT-AI determined the prospective registration status by comparing dates Comparison performed at month level. Registration: 2021-04, LLM Recruitment Start: 2016-12. Deemed retrospective at month level.

Study Design EvidenceDates and timelines extracted by INSPECT-AI from the publication text

Recruitment Start: 12-2016

Recruitment Start Rationale:INSPECT-AI's reasoning for how it identified the recruitment start date Methods: 'The trial was a prospective multicentre, randomized... trial conducted at 8 clinical study sites in Hungary between 2016 and 2020.' Used start of conducted range as recruitment_start per rule 5; no specific FPI elsewhere.

Recruitment End: 02-2019

Recruitment End Rationale:INSPECT-AI's reasoning for how it identified the recruitment end date Results: 'A total of 177 subjects were screened based on the study criteria between December 2016 and February 2019...' Used end of screening as recruitment_finish per rule 5; no specific LPI elsewhere.

Study End: 10-2019

Study End Rationale:INSPECT-AI's reasoning for how it identified the study end date Results: '...and the last follow-up visit was performed in October 2019.' Used final follow-up as study_end_date per rule 4.

Overall — What is the overall integrity assessment of the study?

Automated Assessment:Assessment produced by the automated systemN/A

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsSerious concerns

Rationale: Very delayed registration a major concern.