Trial Outcomes & Findings for Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome) (NCT NCT00743574)

NCT ID: NCT00743574

Last Updated: 2021-08-13

Results Overview

Fasting HbA1C levels at study completion after 3 month treatment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: Completion
• Results posted on: 2021-08-13

Participant Flow

Subjects recruited through flyers, medical clinics, internet postings May 2008-February 2010

Some subjects did not follow through with eligibility testing or had further exclusions, such as scheduling difficulties.

Participant milestones

Measure	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
Overall Study STARTED	36
Overall Study Dropped Out Before Eligibility Testing	13
Overall Study Further Exclusions	8
Overall Study Dropped Out After Initiating Trial	3
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)

Baseline characteristics by cohort

Measure	Vitamin D Plus Calcium (Ca) Supplementation n=12 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26.42 years STANDARD_DEVIATION 6.11 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Baseline HbA1C levels	5.37 percentage STANDARD_DEVIATION 0.53 • n=5 Participants
Baseline insulin levels	24.92 µIU/ml STANDARD_DEVIATION 15.42 • n=5 Participants
Baseline glucose levels	103.79 mg/dl STANDARD_DEVIATION 22.83 • n=5 Participants
Baseline AUC insulin	16136.50 µIU/ml/120 min STANDARD_DEVIATION 10086.29 • n=5 Participants
Baseline AUC for glucose	16648.41 mg/min/120min STANDARD_DEVIATION 3949.98 • n=5 Participants
Baseline C Reactive protein level	5.72 mg/L INTER_QUARTILE_RANGE 1.51-13.93 • n=5 Participants

PRIMARY outcome

Timeframe: Completion

Population: Number determined by those who completed all interventions and procedures.

Fasting HbA1C levels at study completion after 3 month treatment

Outcome measures

Measure

Vitamin D Plus Calcium (Ca) Supplementation n=12 Participants 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

Serum HbA1C at 3 Months

5.55 percentage Standard Deviation 0.66

PRIMARY outcome

Timeframe: 3 months intervention

Population: Number determined by all those who completed all interventions and procedures.

Fasting insulin levels at study completion after 3 month treatment

Outcome measures

Measure

Vitamin D Plus Calcium (Ca) Supplementation n=12 Participants 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

Fasting Insulin Levels at Study Completion After 3 Month Treatment

25.17 µIU/ml Standard Deviation 13.67

PRIMARY outcome

Timeframe: 3 months

Population: Number determined based on all interventions and procedures completed.

Fasting glucose levels drawn after 3 months completion during oral GTT

Outcome measures

Measure

Vitamin D Plus Calcium (Ca) Supplementation n=12 Participants 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

Fasting Glucose Levels at Completion of Treatment, at 3 Months

103.79 mg/dl Standard Deviation 22.83

PRIMARY outcome

Timeframe: 3 months

Population: Number determined by completion of all study interventions and procedures

Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT

Outcome measures

Measure

Vitamin D Plus Calcium (Ca) Supplementation n=12 Participants 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

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 µIU/ml/120min Standard Deviation 10371.76

PRIMARY outcome

Timeframe: 3 months

Population: Number determined by all participants who completed all interventions and procedures

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

Outcome measures

Measure

Vitamin D Plus Calcium (Ca) Supplementation n=12 Participants 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

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 mg/min/120min Standard Deviation 3941.80

SECONDARY outcome

Timeframe: 3 months

Population: All subjects who completed treatment for 3 months

Serum levels of C-reactive protein upon completion, at 3 months

Outcome measures

Measure

Vitamin D Plus Calcium (Ca) Supplementation n=12 Participants 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

Serum Levels of C-reactive Protein at Completion of 3 Months Treatment

5.3 mg/L Interval 1.52 to 14.36

Adverse Events

Vitamin D Plus Calcium (Ca) Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lubna Pal

Yale University

Phone: 203-737-5619

Email: lubna.pal@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place