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| ID | Type | Description | Link |
|---|---|---|---|
| YCCI-CARE Grant #UL1RR024139 |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D plus Calcium (Ca) supplementation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D2 (Ergocalciferol) | Dietary Supplement | 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of C-reactive Protein at Completion of 3 Months Treatment | Serum levels of C-reactive protein upon completion, at 3 months | 3 months |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lubna Pal, MBBS,MRCOG,MSc. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital-Women's Center | New Haven | Connecticut | 06520-8063 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22780885 | Result | 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. | |
| 22981957 | Derived | 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. |
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Some subjects did not follow through with eligibility testing or had further exclusions, such as scheduling difficulties.
Subjects recruited through flyers, medical clinics, internet postings May 2008-February 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D Plus Calcium (Ca) Supplementation | Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months) Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months) Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months) Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
the number of participants for analysis was determined by the number who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D Plus Calcium (Ca) Supplementation | Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months) Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months) Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months) Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Serum Levels of C-reactive Protein at Completion of 3 Months Treatment | Serum levels of C-reactive protein upon completion, at 3 months | All subjects who completed treatment for 3 months | Posted | Median | Inter-Quartile Range | mg/L | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D Plus Calcium (Ca) Supplementation | Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months) Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months) Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months) Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days |
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No limitations
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lubna Pal | Yale University | 203-737-5619 | lubna.pal@yale.edu |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D008525 | Medroxyprogesterone |
| D017258 | Medroxyprogesterone Acetate |
| D002762 | Cholecalciferol |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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 Calcium | Dietary Supplement | 1,000mg (or 2 tablets), PO, daily (supplements taken for three months) |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline HbA1C levels | Fasting HbA1C levels were collected at baseline during a 2 hour oral Glucose Tolerance Test (GTT) | Mean | Standard Deviation | percentage |
|
| Baseline insulin levels | Fasting insulin levels at baseline were drawn during an oral GTT | Mean | Standard Deviation | µIU/ml |
|
| Baseline glucose levels | Fasting glucose levels at baseline were drawn during an oral GTT | Mean | Standard Deviation | mg/dl |
|
| Baseline AUC insulin | Fasting AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)insulin was drawn at baseline during a oral GTT | Mean | Standard Deviation | µIU/ml/120 min |
|
| Baseline AUC for glucose | Fasting level for AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)glucose at baseline was drawn based on oral GTT | Mean | Standard Deviation | mg/min/120min |
|
| Baseline C Reactive protein level | Fasting levels of Creactive protein levels were drawn during oral GTT | Median | Inter-Quartile Range | mg/L |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Serum HbA1C at 3 Months | Fasting HbA1C levels at study completion after 3 month treatment | Number determined by those who completed all interventions and procedures. | Posted | Mean | Standard Deviation | percentage | Completion |
|
|
|
| Primary | Fasting Insulin Levels at Study Completion After 3 Month Treatment | Fasting insulin levels at study completion after 3 month treatment | Number determined by all those who completed all interventions and procedures. | Posted | Mean | Standard Deviation | µIU/ml | 3 months intervention |
|
|
|
| Primary | Fasting Glucose Levels at Completion of Treatment, at 3 Months | Fasting glucose levels drawn after 3 months completion during oral GTT | Number determined based on all interventions and procedures completed. | Posted | Mean | Standard Deviation | mg/dl | 3 months |
|
|
|
| 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 | Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT | Number determined by completion of all study interventions and procedures | Posted | Mean | Standard Deviation | µIU/ml/120min | 3 months |
|
|
|
| Primary | 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 | Number determined by all participants who completed all interventions and procedures | Posted | Mean | Standard Deviation | mg/min/120min | 3 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |