Vitamin D Deficiency in Elderly African American Women in Central Texas

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Osteoporosis; Osteopenia
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment: 60

Contacts and Locations

Study Locations

• United States
  • Texas
    • Waco, Texas, United States, 76643
      • Family Practice Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

African American females aged 70 years or older and non-institutionalized

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Community dwelling elderly black females	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone mineral density	6 week period in 2007

Collaborators and Investigators

• Sponsor: McLennan County Medical Education and Research Foundation
• Collaborators: Procter and Gamble
• Investigators: Principal Investigator: Sally P Weaver, PhD, MD, McLennan County Medical Educ. and Research Foundation; Principal Investigator: H. S. Eugene Fung, MD

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Actual): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Elderly; Vitamin D; African American; Female; Bone mineral density; Calcium; Hyperparathyroidism; Hypoparathyroidism
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Musculoskeletal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases; Vitamin D Deficiency; Osteoporosis; Bone Diseases, Metabolic; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Calcium; Vitamins; Calcium, Dietary; Ergocalciferols
• Other Study ID Numbers: VIT.D.DEF.1