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


N/A
18 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovarian Syndrome, Vitamin D Deficiency

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Trial Information

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


We hypothesize that administering optimal daily doses of Vitamin D3, as recommended by the
National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of Ca, both per oral (PO),
over a three month period in women with PCOS will yield significant results in the
improvement of their condition.


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-alphahydroxylprogesterone 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improve the glycemic profile as demonstrated by levels of HbA1c, fasting insulin/glucose, and the area under the curve for insulin and glucose obtained during a two-hour oral glucose tolerance test (OGTT) compared to baseline.

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Lubna Pal, MBBS,MRCOG,MSc.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

YaleU-0807003992

NCT ID:

NCT00743574

Start Date:

August 2008

Completion Date:

July 2013

Related Keywords:

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

Name

Location
Yale-New Haven Hospital-Women's Center New Haven, Connecticut  06520-8063