NCT00743574

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Polycystic Ovarian Syndrome
• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D2 (Ergocalciferol)	50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
DRUG	Medroxyprogesterone (Provera)	10mg, PO, daily for ten days
DIETARY_SUPPLEMENT	Vitamin D3 (Cholecalciferol)	2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
DIETARY_SUPPLEMENT	Elemental Calcium	1,000mg (or 2 tablets), PO, daily (supplements taken for three months)

Timeline

• Start date: 2008-08-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2008-08-29
• Last updated: 2021-08-13
• Results posted: 2013-07-29

Locations

1 site across 1 country: United States