Clinical trial NCT00743574: Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Official title: Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Vitamin D Deficiency
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2008-08-29
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Serum HbA1C at 3 Months
timeFrame: Completion
measure: Fasting Insulin Levels at Study Completion After 3 Month Treatment
timeFrame: 3 months intervention
measure: Fasting Glucose Levels at Completion of Treatment, at 3 Months
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Serum Levels of C-reactive Protein at Completion of 3 Months Treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Women's Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Lubna Pal, MBBS,MRCOG,MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 2012 Jul 11.
citation: Nardell M, Chhabra A, Pal L. Excluded, not dismissed: enhancing benefit in clinical research. Contemp Clin Trials. 2013 Jan;34(1):70-3. doi: 10.1016/j.cct.2012.08.013. Epub 2012 Sep 7.