Safety of Vitamin D Supplementation in Older Persons

University of Miami

Status and phase: Completed; Phase 3

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: cholecalciferol (vitamin D)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00681590

20070018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 65 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

105 participants in 2 patient groups

1

Active Comparator group

Description:

vitamin D (cholecalciferol) 400 IU daily orally - low dose

Treatment:

Dietary Supplement: cholecalciferol (vitamin D)

Dietary Supplement: cholecalciferol (vitamin D)

2

Active Comparator group

Description:

vitamin D (cholecalciferol) 2000 IU daily orally - high dose

Treatment:

Dietary Supplement: cholecalciferol (vitamin D)

Dietary Supplement: cholecalciferol (vitamin D)