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Clinical Trials

Topic   Bone, Mineral and Metabolism
Title   Safety of Calcium and Vitamin D Supplements at Institute of Medicine Upper Limits Recommendations, A Randomized, Controlled Trial
Summary   Vitamin D and calcium have been known to function together to maintain skeletal health. Vitamin D is obtained through either skin (via sunlight) or food (certain fish, and mostly from fortified foods like milk, cereal, and juices). It then acts on the body to increase absorption of calcium in the intestines and reabsorption of calcium in the kidneys. Decreased calcium absorption in this setting has been shown to be associated with an increase in other hormones which in turn leads to worsening of bone health as well as increased fracture risk.

There has been significant disagreement with respect to optimal vitamin D and calcium supplementation guidelines. In this study we plan to compare the effects of 4,000 IU/ day of vitamin D3 plus 2,000 mg/day of calcium versus placebo plus 2,000 mg/day of calcium on vitamin D and calcium metabolism. The study population will be postmenopausal Caucasian women. We will recruit 260 women to be in the study.
Description   Participation in this study will last approximately 15 months. Up to 260 women will participate in this study. There is a total of 6 visits. Participants will be selected by chance to take either a supplement of vitamin D or placebo (an inactive pill) every day during the study. If their diet does not provide adequate intake of calcium, they will be given dietary instructions for a calcium-rich diet and/or a Calcium pill. Participants must be willing to refrain from the use of self administered vitamin D and calcium supplements during this trial.
IRB Number   17015
Inclusion/Notes   Healthy, ambulatory, Caucasian women, 50 years of age or older, who do not have osteoporosis or take medications for osteoporosis. Participants last menstrual period must be at least two years ago. Participants must be willing to take the study medication and participate for 12 months in the trial.
Status   Open
Start Date   11/01/2017
Principal Name   John F. Aloia, MD
Contact Name   Jane Greensher, RN, MA CCRC
Fax   516-663-4777
Current Trial Type   Interventional
Phone   516-663-3380
Alternate Phone   516-663-2163