Study the Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism.

Completed · Not applicable

Conditions studied: Delusion of Reference

In brief

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.

Key facts

Study ID

NCT02019381

Run by

Winthrop University Hospital

People needed

132

Starts

2013-09-01

Expected to finish

2016-06-01

Last updated by the study team

2016-12-22

Who can join

Age: 50 and older, up to 90. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).
• Willingness to discontinue self-administration of vitamin D and calcium supplements. Participants must be at least three months off supplements before starting the study.
• Willingness to take study medications and participate in study for one year.
• Written informed Consent Signed.
• Patients with hypertension and diabetes stable for last three months.

You may not qualify if…

• History of hypercalciuria (24-hour urinary calcium excretion >250 mg), hypercalcemia (serum calcium >10.6), nephrolithiasis and active sarcoidosis will be excluded.
• Serum 25-hydroxyvitamin D level >80 nmol/L or history of primary hyperparathyroidism.
• Dietary calcium intake of >2000mg/day will be excluded
• 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)
• Treatment with Hormone replacement therapy, Selective Estrogen Receptor Modulators, Calcitonin, Parathyroid hormone , androgens, bisphosphonates, phosphate or anabolic steroids 6 months prior to the study.
• 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.
• 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.
• Unexplained weight loss of >15% during the previous year or history of anorexia nervosa
• > 1 pack per day tobacco use or > 2 alcoholic beverages per day
• Unwillingness to forego self-administration of vitamin D and calcium-containing supplements.
• Participation in another investigational trial in the past 30 days prior to the screening evaluation
• Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator.
• Patients with unstable hypertension or diabetes.

Where it is running

• Winthrop University Hospital — Mineola, New York, United States

Full record on ClinicalTrials.gov

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