Vitamin D Deficiency in Elderly African American Women in Central Texas

McLennan County Medical Education and Research Foundation

Status: Completed

Conditions: Osteopenia; Osteoporosis; Vitamin D Deficiency

Treatments: Behavioral: Usual sun exposure documentation; Procedure: Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH; Drug: Calcium 500mg with 200 IU Vitamin D - 2 tablets daily; Behavioral: Dietary intake of calcium, vitamin D, magnesium

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01971411

VIT.D.DEF.1

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 70 or older woman
2. African American ethnicity
3. Non-institutionalized

Exclusion criteria

1. De-compensated hepatic insufficiency
2. Renal insufficiency with GFR estimated to be < 30 ml/min
3. Gastrointestinal disorders that might affect absorption such as known malabsorption, celiac sprue, short gut or blind loop syndrome.
4. Institutionalized

Trial design

60 participants in 1 patient group

Community dwelling elderly black females

Treatment:

Behavioral: Dietary intake of calcium, vitamin D, magnesium

Behavioral: Usual sun exposure documentation

Procedure: Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH

Drug: Calcium 500mg with 200 IU Vitamin D - 2 tablets daily