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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743574
• Other study ID #: YaleU-0807003992
• Secondary ID: YCCI-CARE Grant
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: February 2013

Study information

• Verified date: August 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Premenopausal women (ages 18-40 years) with normal thyroid function and prolactin levels.

• PCOS diagnosis based on Rotterdam criteria: presence of at least 2 of the following criteria:

• oligomenorrhea-menstrual cycles > 35 day intervals

• hyperandrogenemia (elevated serum testosterone [free or total] &/or androstenedione levels) or features of hyperandrogenism i.e. acne or hirsuitism [Ferriman-Gallaway score > 3]

• polycystic ovaries on vaginal ultrasound as defined by ESHRE/ASRM criteria (ovarian volume = 10mL or = 12 follicles of diameter between 2-9mm in at least one ovary)

• Overweight (BMI = 27 Kg/m2)

• Biochemical evidence of Vitamin D insufficiency (i.e. serum 25 OHD levels < 20ng/mL)

Exclusion Criteria:

• Pregnancy

• Known causes of oligomenorrhea other than PCOS, e.g. hypothyroidism/Cushing's Disease/late onset congenital adrenal hyperplasia (fasting 17-alphahydroxyprogesterone levels < 200ng/dL)

• Use of hormonal treatment (birth control pill/patch/depot medroxyprogesterone/medroxyprogesterone) within 3 months of the study onset.

• Use insulin sensitizers (metformin, sulfonylureas, TZDs, incretins) within 3 months of the study onset.

• Use of lipid lowering agents or medications known to influence insulin sensitivity (e.g. niacin, corticosteroids, beta blockers, calcium channel blockers, thiazide diuretics) or influence serum androgens (estrogen, anti-androgens, androgens) within 3 months of the study onset.

• Known history of renal calculi or current use of Calcium and Vitamin D supplements.

• Spanish Speaking.

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital-Women's Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pal L, Berry A, Coraluzzi L, Kustan E, Danton C, Shaw J, Taylor H. Therapeutic implications of vitamin D and calcium in overweight women with polycystic ovary syndrome. Gynecol Endocrinol. 2012 Dec;28(12):965-8. doi: 10.3109/09513590.2012.696753. Epub 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum HbA1C at 3 Months	Fasting HbA1C levels at study completion after 3 month treatment	Completion
Primary	Fasting Insulin Levels at Study Completion After 3 Month Treatment	Fasting insulin levels at study completion after 3 month treatment	3 months intervention
Primary	Fasting Glucose Levels at Completion of Treatment, at 3 Months	Fasting glucose levels drawn after 3 months completion during oral GTT	3 months
Primary	AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months	Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT	3 months
Primary	AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 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	3 months
Secondary	Serum Levels of C-reactive Protein at Completion of 3 Months Treatment	Serum levels of C-reactive protein upon completion, at 3 months	3 months