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Safety of Vitamin D in the Elderly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00681590
First received: May 15, 2008
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  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 3

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:

MedlinePlus related topics: 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 by University of Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 May 19, 2013