Vitamin D Deficiency in Elderly African American Women in Central Texas

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
McLennan County Medical Education and Research Foundation
ClinicalTrials.gov Identifier:
NCT01971411
First received: April 23, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Osteoporosis
Osteopenia
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vitamin D Deficiency in Elderly African American Women in Central Texas

Resource links provided by NLM:


Further study details as provided by McLennan County Medical Education and Research Foundation:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: 6 week period in 2007 ]

Estimated Enrollment: 60
Study Start Date: March 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01971411

Locations
United States, Texas
Family Practice Center
Waco, Texas, United States, 76643
Sponsors and Collaborators
McLennan County Medical Education and Research Foundation
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
  More Information

Publications:
Responsible Party: McLennan County Medical Education and Research Foundation
ClinicalTrials.gov Identifier: NCT01971411     History of Changes
Other Study ID Numbers: VIT.D.DEF.1
Study First Received: April 23, 2013
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by McLennan County Medical Education and Research Foundation:
Hyperparathyroidism
Hypoparathyroidism
Calcium
Vitamin D
Bone mineral density
African American
Female
Elderly

Additional relevant MeSH terms:
Osteoporosis
Vitamin D Deficiency
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014