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Clinical Trials

Topic   Bone, Mineral and Metabolism
Title   A New Paradigm for Vitamin D Sufficiency: A 6-month, randomized, double blind, placebo-controlled study to investigate vitamin D status in elderly Caucasian women
Summary   Vitamin D is a hormone that is produced when sunlight is absorbed by the skin. Vitamin D deficiency (not enough or a lack of Vitamin D in the body) has been recognized as a problem in areas where sun exposure is limited, especially in the wintertime. Vitamin D plays an important role in helping the body absorb calcium and in building strong bones. It can also improve muscle function in the elderly, decreasing the risk for falls and fractures.

It has been shown that there are differences in bone health between African Americans and European Americans. Particularly, African Americans have higher bone mass and half the chance of getting osteoporosis and fragility fractures than Caucasian Americans. Recently, it has also been shown that there are differences in the way different races process Vitamin D, and African Americans tend to have lower Vitamin D levels in the blood than Caucasians despite the better bone health. However, the current recommendations for daily dose of Vitamin D are the same for both races, and the standard laboratory test used by most clinicians is also the same for both races despite these important differences.

The main purpose of this study is to determine if two new tests for Vitamin D levels in the blood can provide a better measure of Vitamin D and can be used equally in African Americans and European Americans. We also want to determine if there are other differences in response to Vitamin D between the two races. We have already done this study on 260 African American women. With this new study, we will compare those results with 260 Caucasian women. This will help in making more accurate future recommendations on Vitamin D testing and Vitamin D intake.
Description   Participation in this study will last approximately 6 months. Up to 260 women will participate in this study. There is a total of 4 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   16001
Inclusion/Notes   Healthy, ambulatory, Caucasian women, 60 years of age or older, who do not have osteoporosis or take medications for osteoporosis. Participants last menstrual period must be at least five years ago. Participants must be willing to take the study medication and participate for six months in the trial.
Principal Name   Jane S. Greensher, RN, MA, CCRC
Email   jsgreensher@nyuwinthrop.org
Phone   (516) 663 3380
Alternate Phone   (516) 663 2163