Polycystic Ovarian SyndromeNCT00743574
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
A study testing Vitamin D2 (Ergocalciferol), Medroxyprogesterone (Provera) and Vitamin D3 (Cholecalciferol) in people with Polycystic Ovarian Syndrome and Vitamin D Deficiency, run by Yale University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome, Vitamin D Deficiency
- What is being tested?
- Vitamin D2 (Ergocalciferol), Medroxyprogesterone (Provera) and Vitamin D3 (Cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital-Women's Center
New Haven, Connecticut, 06520-8063
About this study
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).
Read the 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.
- Conditions
- Polycystic Ovarian Syndrome, Vitamin D Deficiency
- Being tested
- Vitamin D2 (Ergocalciferol), Medroxyprogesterone (Provera), Vitamin D3 (Cholecalciferol), Elemental Calcium
- Medical subject headings
- Polycystic Ovary Syndrome, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2 (Ergocalciferol)Dietary supplement
50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera)Drug
10mg, PO, daily for ten days
Vitamin D3 (Cholecalciferol)Dietary supplement
2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental CalciumDietary supplement
1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D plus Calcium (Ca) supplementation | Experimental | Not described Receives: Dietary Supplement: Vitamin D2 (Ergocalciferol); Drug: Medroxyprogesterone (Provera); Dietary Supplement: Vitamin D3 (Cholecalciferol); Dietary Supplement: Elemental Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum HbA1C at 3 Months
Fasting HbA1C levels at study completion after 3 month treatment
Measured: Completion
Fasting Insulin Levels at Study Completion After 3 Month Treatment
Fasting insulin levels at study completion after 3 month treatment
Measured: 3 months intervention
Fasting Glucose Levels at Completion of Treatment, at 3 Months
Fasting glucose levels drawn after 3 months completion during oral GTT
Measured: 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
Measured: 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
Measured: 3 months
Secondary outcomes (1)
Serum Levels of C-reactive Protein at Completion of 3 Months Treatment
Serum levels of C-reactive protein upon completion, at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Lubna Pal, MBBS,MRCOG,MSc., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743574
- Sponsor's protocol ID
- YaleU-0807003992
- Other IDs
- YCCI-CARE Grant #UL1RR024139
- Status last verified
- Aug 2021
- First submitted
- 28 Aug 2008
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22780885Nardell 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.
PubMed 22981957
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
- ClinicalTrials.gov ID
- NCT00743574
- Acronym / sponsor ID
- YaleU-0807003992
- Conditions
- Polycystic Ovarian Syndrome, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Aug 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Posted 29 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D plus Calcium (Ca) supplementation | Experimental | Dietary Supplement: Vitamin D2 (Ergocalciferol), Drug: Medroxyprogesterone (Provera), Dietary Supplement: Vitamin D3 (Cholecalciferol), Dietary Supplement: Elemental Calcium |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2 (Ergocalciferol)50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months) | Dietary supplement | Vitamin D plus Calcium (Ca) supplementation |
| Medroxyprogesterone (Provera)10mg, PO, daily for ten days | Drug | Vitamin D plus Calcium (Ca) supplementation |
| Vitamin D3 (Cholecalciferol)2,000IU (or 2 tablets), PO, daily (supplements taken for three months) | Dietary supplement | Vitamin D plus Calcium (Ca) supplementation |
| Elemental Calcium1,000mg (or 2 tablets), PO, daily (supplements taken for three months) | Dietary supplement | Vitamin D plus Calcium (Ca) supplementation |
Primary outcome
Serum HbA1C at 3 Months
Time frame: Completion
Fasting HbA1C levels at study completion after 3 month treatment
Fasting Insulin Levels at Study Completion After 3 Month Treatment
Time frame: 3 months intervention
Fasting insulin levels at study completion after 3 month treatment
Fasting Glucose Levels at Completion of Treatment, at 3 Months
Time frame: 3 months
Fasting glucose levels drawn after 3 months completion during oral GTT
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
Time frame: 3 months
Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT
AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months
Time frame: 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
1 secondary outcome
Serum Levels of C-reactive Protein at Completion of 3 Months Treatment
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22780885Pal 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.
- Derived from this study: PubMed 22981957Nardell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lubna Pal, MBBS,MRCOG,MSc. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D2 (Ergocalciferol), Medroxyprogesterone (Provera) and Vitamin D3 (Cholecalciferol) in people with Polycystic Ovarian Syndrome and Vitamin D Deficiency, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum HbA1C at 3 Months (time frame: Completion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00743574, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.