Clinical trial NCT01971411: Vitamin D Deficiency in Elderly African American Women in Central Texas
Official title: Vitamin D Deficiency in Elderly African American Women in Central Texas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Osteoporosis
Osteopenia
Keywords: Hyperparathyroidism
Hypoparathyroidism
Calcium
Vitamin D
Bone mineral density
African American
Female
Elderly
Lead sponsor: McLennan County Medical Education and Research Foundation
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2013-10-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American females aged 70 years or older and non-institutionalized

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.

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

Primary outcomes:
measure: Bone mineral density
timeFrame: 6 week period in 2007
Secondary outcomes:
Other outcomes:
Locations:
city: Waco
country: United States
facility: Family Practice Center
state: Texas
Study officials:
affiliation: McLennan County Medical Educ. and Research Foundation
name: Sally P Weaver, PhD, MD
role: PRINCIPAL_INVESTIGATOR
name: H. S. Eugene Fung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.