CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Medroxyprogesterone (Provera) +3 moredrug
Likely dose
Medroxyprogesterone (Provera) 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00743574
NCT00743574N/ACompleted
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Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)

Yale University·interventional·Posted Aug 29, 2008·Updated Aug 13, 2021

In Brief

A clinical study evaluating Vitamin D2 (Ergocalciferol), Medroxyprogesterone (Provera), and 2 other interventions for Polycystic Ovarian Syndrome and Vitamin D Deficiency. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation in overweight (BMI \> 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels \< 20 ng/mL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovarian Syndrome, Vitamin D Deficiency
CountriesUnited States
CollaboratorsNational Center for Research Resources (NCRR)

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2008
Enrollment StartAug 1, 2008
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.8 years ago

Interventions

Vitamin D2 (Ergocalciferol)dietary

50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)

Medroxyprogesterone (Provera)drug

10mg, PO, daily for ten days

Vitamin D3 (Cholecalciferol)dietary

2,000IU (or 2 tablets), PO, daily (supplements taken for three months)

Elemental Calciumdietary

1,000mg (or 2 tablets), PO, daily (supplements taken for three months)