Safety of Vitamin D Supplementation in Older Persons

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00681590
Recruitment Status : Completed
First Posted : May 21, 2008
Results First Posted : March 7, 2016
Last Update Posted : January 26, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Silvina Levis, MD, University of Miami

Brief Summary:
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 or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: cholecalciferol (vitamin D) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety of Vitamin D Supplementation in the Elderly
Study Start Date : April 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Number of Participants Who Develop Hypercalcemia [ Time Frame: 6 months ]
    calcium serum levels measured at baseline and at the end of the intervention (6-months)

Secondary Outcome Measures :
  1. Change From Baseline in Serum 25-hydroxyvitamin D Levels [ Time Frame: baseline and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00681590

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

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Silvina Levis, MD, Professor, University of Miami Identifier: NCT00681590     History of Changes
Other Study ID Numbers: 20070018
First Posted: May 21, 2008    Key Record Dates
Results First Posted: March 7, 2016
Last Update Posted: January 26, 2017
Last Verified: December 2016

Keywords provided by Silvina Levis, MD, University of Miami:
vitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents