Vitamin D Deficiency in Elderly African American Women in Central Texas

NCT ID: NCT01971411

Last Updated: 2018-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-05-31

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.

Conditions

Vitamin D Deficiency; Osteoporosis; Osteopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Community dwelling elderly black females

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

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

Usual sun exposure documentation

Intervention Type: BEHAVIORAL

Dietary intake of calcium, vitamin D, magnesium

Intervention Type: BEHAVIORAL

Interventions

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

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

Usual sun exposure documentation

Intervention Type: BEHAVIORAL

Dietary intake of calcium, vitamin D, magnesium

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

McLennan County Medical Education and Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sally P Weaver, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

McLennan County Medical Educ. and Research Foundation

H. S. Eugene Fung, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Family Practice Center

Waco, Texas, United States

Countries

United States

References

Weaver SP, Passmore C, Collins B, Fung E. Vitamin D, sunlight exposure, and bone density in elderly African American females of low socioeconomic status. Fam Med. 2010 Jan;42(1):47-51.

Reference Type: RESULT

PMID: 20063223 (View on PubMed)

Other Identifiers

VIT.D.DEF.1

Identifier Type: -

Identifier Source: org_study_id