Yale-New Haven Hospital-Women's Center
New Haven, Connecticut, 06520-8063, United States
NCT Number: NCT00743574
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).
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Notify Me18 year–40 year
Female
Interventional
Not applicable
New Haven, Connecticut, 06520-8063, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
10mg, PO, daily for ten days
2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Time frame: Completion
Fasting HbA1C levels at study completion after 3 month treatment
Time frame: 3 months intervention
Fasting insulin levels at study completion after 3 month treatment
Time frame: 3 months
Fasting glucose levels drawn after 3 months completion during oral GTT
Time frame: 3 months
Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT
Time frame: 3 months
AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT
Time frame: 3 months
Serum levels of C-reactive protein upon completion, at 3 months
Yale University
Other
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