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.
The specific aims of this study proposal are to determine the following: 1. To compare the two different intake guidelines for Calcium and Vitamin D Supplementation at its recommended tolerable upper limit on serum and urinary calcium in white postmenopausal Women. 2. Compare the effects above mentioned two intake guidelines on Vitamin D metabolism \[25(OH)D, 1,25(OH)2D\] and bone turnover. Participants will be randomly assigned to Group A or Group B based on different dosages of study medications. Group A: 10,000 IU (International Units)Vitamin D + Placebo (sugar pill) 600IU Vitamin D + Two pills Calcium containing 600mg calcium each. Group B: 600 IU Vitamin D + Placebo (sugar pill) 10,000 IU Vitamin D \+ Two pills Calcium containing 600mg calcium each. In addition to the calcium supplements, they will guide to include approximately 800mg of calcium in their daily diet. At visit 2, fasting blood and spot urine will be collected. A urinal will be dispensed for collection of 24-hour urine for urinary calcium to be brought in next day. Study medication will be dispensed and participants will be asked not to discard unused medications and to bring all study medications next study visit. Visit 3, 4, 5, 6 will essentially be the same as visit 2, with subjects returning unused study medication and given new tablets each visit. Except on visit 6 no further study medications will be dispensed, after collecting the previous supply. Food frequency questionnaires will be filled out at the initial visit and final visit. Diet will be assessed using 3-day diet history form and Nutrition Pro analysis software. Patients will be asked to refrain from taking other Vitamin D supplements and to continue their usual calcium intake.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
132
Endocrine Upper limit arm will get 10,000IU Vitamin D and 1200mg Calcium
IOM arm will get 600 IU Vitamin D and 1,200 mg Calcium
1200mg of CaCO3 supplementation will be given to each participant in both groups
Winthrop University Hospital
Mineola, New York, United States
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.
Time frame: One year
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.
Time frame: One year
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