Safety of Vitamin D in the Elderly - Full Text View

Sponsor:	University of Miami
Collaborator:	Merck
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00681590

Purpose

This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.

Condition	Intervention	Phase
Vitamin D Deficiency	Dietary Supplement: cholecalciferol (vitamin D)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Safety of Vitamin D Supplementation in the Elderly

Resource links provided by NLM:

Genetics Home Reference related topics: carbamoyl phosphate synthetase I deficiency

MedlinePlus related topics: Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:

To establish the safety of a daily intake of vitamin D (cholecalciferol) of 2000 IU over 6 months in men and women ages 65 to 95 years. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the efficacy of vitamin D (cholecalciferol) supplementation in improving measures of physical performance. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2008
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 vitamin D (cholecalciferol) 400 IU	Dietary Supplement: cholecalciferol (vitamin D) 400 IU daily
Active Comparator: 2 vitamin D (cholecalciferol) 2000 IU	Dietary Supplement: cholecalciferol (vitamin D) 2000 IU daily

Detailed Description:

120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will participate in the clinical trial for 6 months.

Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically. Physical performance will be tested at baseline and throughout the study.

Eligibility

Ages Eligible for Study:	65 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

ambulatory

Exclusion Criteria:

hypercalcemia
hypercalciuria > 4 mg/kg body weight/day
primary, secondary, or tertiaryhyperparathyroidism
renal insufficiency (serum creatinine > 2 mg/dL )
history of nephrolithiasis
treatment with vitamin D (ergocalciferol, cholecalciferol, caltitriol)
treatment with anticonvulsants
Paget's disease
severe cardiac, pulmonary, hepatic, renal, or neurological disease
life expectancy < 1 year
participation in another trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681590

Contacts

Contact: Luis Rochel, RN	305 243-4012	Lrochel@med.miami.edu
Contact: Silvina Levis, MD	305 243-4330	slevis@med.miami.edu

Locations

United States, Florida
University of Miami	Recruiting
Miami, Florida, United States, 33136
Contact: Luis Rochel, RN 305-243-4012 lrochel@med.miami.edu
Contact: Silvina Levis, MD 305 243-4330 slevis@med.miami.edu

Sponsors and Collaborators

University of Miami

Merck

Investigators

Principal Investigator:

Silvina Levis, MD

University of Miami

More Information

No publications provided

Responsible Party:	Silvina Levis, MD, University of Miami
ClinicalTrials.gov Identifier:	NCT00681590 History of Changes
Other Study ID Numbers:	20070018
Study First Received:	May 15, 2008
Last Updated:	May 19, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

vitamin D
deficiency
elderly

Additional relevant MeSH terms:

Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D

Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 09, 2012