Vitamin D Deficiency in Elderly African American Women in Central Texas

Status Completed

Clinical Trial Summary

In order to make bone health a reality for older adults, we need to consider the prevalence of Vitamin D deficiency in relation to environment latitude as well as vitamin D supplementation. Darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D. The aim of this project is to document vitamin D deficiency in elderly African American women living in a southern latitude.

Clinical Trial Description

Summary: Since darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D, we hypothesize that: 1) the usual sun exposure in the southern United States may not be sufficient to maintain adequate vitamin D levels in elderly African American women, 2) recommended supplementation of Vitamin D 400 IU/d may not be adequate to prevent Vitamin D deficiency which in turn could lead to calcium deficiency and possibly sub-clinical hyperparathyroidism.

This study will enroll 60 African American women age 65 or older who do not have renal, hepatic or gastrointestinal disorders that could affect Vitamin D and calcium absorption and metabolism. Patients will have two scheduled office visits. Demographic data will be collected with attention to dietary intake of calcium and vitamin D, and the patient's customary degree of sun exposure. Ca, 25-hydroxyvitamin D, PTH and serum CTX (a bone resorption marker) are measured on enrollment day and repeated 6 weeks later. All patients not already taking 1000 mg Calcium with 400 IU of Vitamin D orally daily were given samples of this supplement to last for 6 weeks without making any change in diet or sun exposure recommendations. The study period will extend April to June - a time when there should be ample sunlight but it is not so hot as to stop the elderly from going outdoors. Statistical analysis will be performed as to the effect(s) of ethnic background, age, diet, and intensity of sun exposure as related to Ca, 25-hydroxyvitamin D, PTH and serum CTX. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01971411
Study type	Observational
Source	McLennan County Medical Education and Research Foundation
Contact
Status	Completed
Phase
Start date	March 2006
Completion date	May 2007

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.