Delusion of Reference Clinical Trial
Official title:
The Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism in Postmenopausal White Women.
| Verified date | December 2016 |
| Source | Winthrop University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Recently two distinguished committees, Institute of Medicine (IOM) and The Endocrine Society have proposed different intake guidelines for Calcium and Vitamin D. We wish to compare the effects of both of them on calcium metabolism and bone turnover. We propose a one year randomized double blinded study for the same.
| Status | Completed |
| Enrollment | 132 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 50 Years to 90 Years |
| Eligibility |
Inclusion Criteria: 1. Healthy White women aged 50 and older who have been postmenopausal for at least 2 year (i.e. absence of menstrual period for a period of 24 months or more). 2. Willingness to discontinue self-administration of vitamin D and calcium supplements. Participants must be at least three months off supplements before starting the study. 3. Willingness to take study medications and participate in study for one year. 4. Written informed Consent Signed. 5. Patients with hypertension and diabetes stable for last three months. Exclusion Criteria: 1. History of hypercalciuria (24-hour urinary calcium excretion >250 mg), hypercalcemia (serum calcium >10.6), nephrolithiasis and active sarcoidosis will be excluded. 2. Serum 25-hydroxyvitamin D level >80 nmol/L or history of primary hyperparathyroidism. 3. Dietary calcium intake of >2000mg/day will be excluded 4. Use of medication that influences bone or vitamin D metabolism (e.g. anticonvulsant medications, glucocorticoids, Highly Active AntiRetroviral Therapy [AIDS treatment], antirejection medications, chronic use of steroids, high dose diuretics) 5. Treatment with Hormone replacement therapy, Selective Estrogen Receptor Modulators, Calcitonin, Parathyroid hormone , androgens, bisphosphonates, phosphate or anabolic steroids 6 months prior to the study. 6. Use of systemic steroids (oral or intravenous) within the last year at an average dose of more than 5mg/day of oral prednisone or an equivalent for a period of three months or more prior to screening. 7. Chronic medical illness including Chronic liver disease, uncontrolled diabetes mellitus; recent history of myocardial infarction or heart failure; newly diagnosed or active malignancy; uncontrolled hypertension; obesity (BMI>35 kg/m2); malabsorption, anemia, leukemia, or other hematologic abnormalities; lupus, rheumatoid arthritis, sarcoidosis, or other rheumatologic disease; chronic kidney disease, metabolic bone disease. 8. Unexplained weight loss of >15% during the previous year or history of anorexia nervosa 9. > 1 pack per day tobacco use or > 2 alcoholic beverages per day 10. Unwillingness to forego self-administration of vitamin D and calcium-containing supplements. 11. Participation in another investigational trial in the past 30 days prior to the screening evaluation 12. Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator. 13. Patients with unstable hypertension or diabetes. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United States | Winthrop University Hospital | Mineola | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Winthrop University Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Compare the effects of 10000 IU/day vitamin D plus 2,000 mg/day calcium versus 600 IU/day vitamin D plus 2,000 mg/day calcium on incidence of hypercalciuria (spot urine calcium:creatinine ratio, 24-hour urine calcium). | Endocrine society has recommended tolerable upper limit or a dose with no adverse events as 10,000IU of Vitamin D and 2000 mg/day of calcium. Our study will test the safety/ efficacy of this recommendation. | One year | Yes |
| Secondary | Compare the effects of 10,000 IU/day vitamin D plus 2,000 mg/day calcium versus 600 IU/day vitamin D plus 2,000 mg/day calcium on vitamin D metabolism [25(OH)D, 1,25(OH)2D], and bone turnover. | To test safety/efficacy of The Endocrine Society recommendations on Bone turnover. | One year | Yes |