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Safety of Vitamin D Supplementation in Older Persons

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Silvina Levis, MD, University of Miami
ClinicalTrials.gov Identifier:
NCT00681590
First received: May 15, 2008
Last updated: February 5, 2016
Last verified: February 2016
  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:
  • Number of Participants Who Develop Hypercalcemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Serum 25-hydroxyvitamin D Levels [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
vitamin D (cholecalciferol) 400 IU daily orally - low dose
Dietary Supplement: cholecalciferol (vitamin D)
400 IU daily (low dose)
Active Comparator: 2
vitamin D (cholecalciferol) 2000 IU daily orally - high dose
Dietary Supplement: cholecalciferol (vitamin D)
2000 IU daily (high dose)

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   (Adult, Senior)
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 tertiary hyperparathyroidism
  • renal insufficiency (serum creatinine > 2 mg/dL )
  • history of nephrolithiasis
  • treatment with vitamin D (ergocalciferol, cholecalciferol, calcitriol)
  • 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

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Silvina Levis, MD University of Miami
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Silvina Levis, MD, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00681590     History of Changes
Other Study ID Numbers: 20070018 
Study First Received: May 15, 2008
Results First Received: February 5, 2016
Last Updated: February 5, 2016
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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on December 02, 2016