NCT01971411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

April 23, 2013

Last Update Submit

March 28, 2018

Conditions

Vitamin D DeficiencyOsteoporosisOsteopenia

Keywords

HyperparathyroidismHypoparathyroidismCalciumVitamin DBone mineral densityAfrican AmericanFemaleElderly

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    6 week period in 2007

Study Arms (1)

Community dwelling elderly black females

Drug: Calcium 500mg with 200 IU Vitamin D - 2 tablets dailyProcedure: Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTHBehavioral: Usual sun exposure documentationBehavioral: Dietary intake of calcium, vitamin D, magnesium

Interventions

Calcium 500mg with 200 IU Vitamin D - 2 tablets dailyDRUG
Community dwelling elderly black females
Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTHPROCEDURE
Community dwelling elderly black females
Usual sun exposure documentationBEHAVIORAL
Community dwelling elderly black females
Dietary intake of calcium, vitamin D, magnesiumBEHAVIORAL
Community dwelling elderly black females

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 70 or older woman
  • African American ethnicity
  • Non-institutionalized

You may not qualify if:

  • De-compensated hepatic insufficiency
  • Renal insufficiency with GFR estimated to be \< 30 ml/min
  • Gastrointestinal disorders that might affect absorption such as known malabsorption, celiac sprue, short gut or blind loop syndrome.
  • Institutionalized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Practice Center

Waco, Texas, 76643, United States

Location

Related 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.

    PMID: 20063223RESULT

MeSH Terms

Conditions

Vitamin D DeficiencyOsteoporosisBone Diseases, MetabolicHyperparathyroidismHypoparathyroidism

Interventions

CalciumErgocalciferolsVitamin DMagnesium

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipidsMetals, Light

Study Officials

  • Sally P Weaver, PhD, MD

    McLennan County Medical Educ. and Research Foundation

    PRINCIPAL INVESTIGATOR

  • H. S. Eugene Fung, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

October 29, 2013

Study Start

March 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

US(1)