NCT01971411

Vitamin D Deficiency in Elderly African American Women in Central Texas

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (planned)
• Sponsor: McLennan County Medical Education and Research Foundation · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Vitamin D Deficiency
• Osteoporosis
• Osteopenia

Interventions

Type	Name	Description
DRUG	Calcium 500mg with 200 IU Vitamin D - 2 tablets daily
PROCEDURE	Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH
BEHAVIORAL	Usual sun exposure documentation
BEHAVIORAL	Dietary intake of calcium, vitamin D, magnesium

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2013-10-29
• Last updated: 2018-03-30

Locations

1 site across 1 country: United States