Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
2 other identifiers
interventional
36
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 28, 2008
CompletedFirst Posted
Study publicly available on registry
August 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
July 29, 2013
CompletedAugust 13, 2021
August 1, 2021
4.5 years
August 28, 2008
February 15, 2013
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
Serum HbA1C at 3 Months
Fasting HbA1C levels at study completion after 3 month treatment
Completion
Fasting Insulin Levels at Study Completion After 3 Month Treatment
Fasting insulin levels at study completion after 3 month treatment
3 months intervention
Fasting Glucose Levels at Completion of Treatment, at 3 Months
Fasting glucose levels drawn after 3 months completion during oral GTT
3 months
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
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 Outcomes (1)
Serum Levels of C-reactive Protein at Completion of 3 Months Treatment
3 months
Study Arms (1)
Vitamin D plus Calcium (Ca) supplementation
EXPERIMENTALInterventions
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)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Center for Research Resources (NCRR)collaborator
Study Sites (1)
Yale-New Haven Hospital-Women's Center
New Haven, Connecticut, 06520-8063, United States
Related Publications (2)
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.
PMID: 22780885RESULTNardell 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.
PMID: 22981957DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No limitations
Results Point of Contact
- Title
- Dr. Lubna Pal
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Lubna Pal, MBBS,MRCOG,MSc.
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2008
First Posted
August 29, 2008
Study Start
August 1, 2008
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
August 13, 2021
Results First Posted
July 29, 2013
Record last verified: 2021-08