NCT02019381

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

The Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism in Postmenopausal White Women.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Winthrop University Hospital · Academic / Other
• Sex: Female
• Age: 50 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Delusion of Reference

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Endocrine Society UL Dosage Vitamin D	Endocrine Upper limit arm will get 10,000IU Vitamin D and 1200mg Calcium
DIETARY_SUPPLEMENT	Institute of Medicine Dosage Vitamin D	IOM arm will get 600 IU Vitamin D and 1,200 mg Calcium
DIETARY_SUPPLEMENT	Calcium	1200mg of CaCO3 supplementation will be given to each participant in both groups

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-12-24
• Last updated: 2016-12-22

Locations

1 site across 1 country: United States