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Completed

NCT Number: NCT00681590

Safety of Vitamin D Supplementation in Older Persons

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cholecalciferol (Vitamin D)

Dietary Supplement

400 IU daily (low dose)

Primary outcomes

  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 outcomes

  1. Change From Baseline in Serum 25-hydroxyvitamin D Levels

    Time frame: baseline and 6 months

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Safety of Vitamin D Supplementation in the Elderly

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 21, 2008
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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