Vitamin D Deficiency in Elderly African American Women in Central Texas

Completed

• Conditions: Vitamin D Deficiency; Osteoporosis; Osteopenia
• Interventions: 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

• Registration Number: NCT01971411
• Lead Sponsor: McLennan County Medical Education and Research Foundation

Brief 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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Community dwelling elderly black females	Calcium 500mg with 200 IU Vitamin D - 2 tablets daily	-
Community dwelling elderly black females	Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH	-
Community dwelling elderly black females	Usual sun exposure documentation	-
Community dwelling elderly black females	Dietary intake of calcium, vitamin D, magnesium	-

Primary Outcome Measures

Name	Time	Method
Bone mineral density	6 week period in 2007

Trial Locations

Locations (1)

Family Practice Center; 🇺🇸 Waco, Texas, United States