Vitamin D Deficiency in Elderly African American Women in Central Texas

Osteoporosis Clinical Trial

Official title:

Vitamin D Deficiency in Elderly African American Women in Central Texas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971411
• Other study ID #: VIT.D.DEF.1
• Status: Completed
• First received: April 23, 2013
• Last updated: March 28, 2018
• Start date: March 2006
• Est. completion date: May 2007

Study information

• Verified date: March 2018
• Source: McLennan County Medical Education and Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis
• Vitamin D Deficiency

Intervention

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

• Dietary intake of calcium, vitamin D, magnesium

Locations

Country	Name	City	State
United States	Family Practice Center	Waco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
McLennan County Medical Education and Research Foundation	Procter and Gamble

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density		6 week period in 2007