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Vitamin D and Polycystic Ovarian Syndrome (PCOS)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 19, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Jun 30, 2024 to Jun 30, 2025 Completion date: Jun 13, 2025 to Jul 13, 2025v4 Show 1 more changeShow less
    • Completion date: Jun 13, 2025 to Jul 13, 2025
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jan 1, 2023 to Jun 30, 2024 · Start date changed from estimate of Jan 1, 2022 to Feb 1, 2023 · Study sites: 1 to 2 · 4 morev3 Show 7 more changesShow less
    • Primary completion date: Jan 1, 2023 to Jun 30, 2024
    • Start date changed from estimate of Jan 1, 2022 to Feb 1, 2023
    • Study sites: 1 to 2
    • Completion date: Jun 13, 2023 to Jun 13, 2025
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description shortened, about 6 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Primary completion date: Dec 31, 2021 to Jan 1, 2023 Start date: Jan 1, 2020 to Jan 1, 2022 · Completion date: Jun 13, 2022 to Jun 13, 2023v2 Show 2 more changesShow less
    • Start date: Jan 1, 2020 to Jan 1, 2022
    • Completion date: Jun 13, 2022 to Jun 13, 2023
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Primary Objectives: To evaluate the efficacy of metformin and Vitamin D supplementation on serum insulin and serum androgen levels (Total testosterone, Steroid Hormone Binding Globulin, Free Androgen Index) levels compared metformin alone in infertile Poly cystic ovarian females of reproductive age group. Secondary Objectives: To measure change in endometrial thickness/number of follicles and follicular size by day 12 trans-vaginal ultrasound in the intervention group i.e. combination of metformin and vitamin D supplementation
Trial Details
NCT Number NCT03989778
Lead Sponsor Aga Khan University
Conditions Infertility, Female, Infertility, Vitamin D Deficiency
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov