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 Sharp & Dohme Corp.
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00681590
First received: May 15, 2008
Last updated: May 19, 2008
Last verified: May 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
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
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014