N/A
N=36
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Polycystic Ovarian Syndrome · Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT00743574 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Serum HbA1C at 3 Months — 5.55 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D2 (Ergocalciferol) (Dietary_supplement); Medroxyprogesterone (Provera) (Drug); Vitamin D3 (Cholecalciferol) (Dietary_supplement); Elemental Calcium (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum HbA1C at 3 Months |
5.55 | — |
| PRIMARY Fasting Insulin Levels at Study Completion After 3 Month Treatment |
25.17 | — |
| PRIMARY Fasting Glucose Levels at Completion of Treatment, at 3 Months |
103.79 | — |
| 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 |
16715.57 | — |
| PRIMARY AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months |
16726.56 | — |
| SECONDARY Serum Levels of C-reactive Protein at Completion of 3 Months Treatment |
5.3 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00743574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.