deltatrials
Completed NA INTERVENTIONAL 1-arm NCT00743574

Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)

Sponsor: National Center for Research Resources (NCRR)

Updated 10 times since 2017 Last updated: Aug 11, 2021 Started: Aug 31, 2008 Primary completion: Feb 28, 2013 Completion: Feb 28, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Polycystic Ovarian Syndrome and Vitamin D Deficiency and is currently completed. National Center for Research Resources (NCRR) leads this study, which shows 10 recorded versions since 2008 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

We had hypothesized that in women with PCOS, administering optimal daily doses of vitamin D3, as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of calcium, both per oral (PO), over a three month period will improve their metabolic picture, and possibly hormone profile. Over the course of the trial, after the first 5 subjects had completed 3 month intervention,we observed that daily 2000IU D3 dosing regime was inadequate in normalizing vitamin D status in the study population; the dosing regimen was therefore modified to include weekly supplementation with 50,000IU D2 in addition to daily dosing with 2000IU D3.

We had hypothesized that in women with PCOS, administering optimal daily doses of vitamin D3, as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of calcium, both per oral (PO), over a three month period will improve their metabolic picture, and possibly hormone profile.

Over the course of the trial, after the first 5 subjects had completed 3 month intervention,we observed that daily 2000IU D3 dosing regime was inadequate in normalizing vitamin D status in the study population; the dosing regimen was therefore modified to include weekly supplementation with 50,000IU D2 in addition to daily dosing with 2000IU D3.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotCompleted~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshotCompleted~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Jan 2023 — Jul 2024 [monthly]

    Completed NA

  5. Dec 2022 — Jan 2023 [monthly]

    Completed NA

Show 5 earlier versions
  1. Dec 2021 — Dec 2022 [monthly]

    Completed NA

  2. Sep 2021 — Dec 2021 [monthly]

    Completed NA

  3. Jan 2021 — Sep 2021 [monthly]

    Completed NA

  4. Jun 2018 — Jan 2021 [monthly]

    Completed NA

  5. Jan 2017 — Jun 2018 [monthly]

    Completed NA

    First recorded

Aug 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Center for Research Resources (NCRR)
  • Yale University
Data source: Yale University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations