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Vitamin D Deficiency in Elderly African American Women in Central Texas

Vitamin D Deficiency in Elderly African American Women in Central Texas

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01971411
Enrollment
60
Registered
2013-10-29
Start date
2006-03-31
Completion date
2007-05-31
Last updated
2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia, Osteoporosis, Vitamin D Deficiency

Keywords

Hyperparathyroidism, Hypoparathyroidism, Calcium, Vitamin D, Bone mineral density, African American, Female, Elderly

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.

Interventions

DRUGCalcium 500mg with 200 IU Vitamin D - 2 tablets daily
PROCEDUREBlood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH
BEHAVIORALUsual sun exposure documentation
BEHAVIORALDietary intake of calcium, vitamin D, magnesium

Sponsors

Procter and Gamble
CollaboratorINDUSTRY
McLennan County Medical Education and Research Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Bone mineral density6 week period in 2007

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026