Optimizing Vitamin D in the Elderly

Not Applicable

Completed

• Conditions: Deficiency of Vitamin D3
• Interventions: Dietary Supplement: D3 2000 IU/day; Dietary Supplement: vitamin D3 800 IU/day; Dietary Supplement: D3 4000 IU/day; Dietary Supplement: D3 50,000 IU weekly

• Registration Number: NCT01554241
• Lead Sponsor: University of California, San Francisco

Brief Summary

Vitamin D deficiency is highly prevalent in older people in the absence of vitamin D supplementation. The limited data available show marked inter-individual variability in response to vitamin D supplementation in very old, frail elderly with almost 25% remaining vitamin D deficient (25-OH D \< 20 ng/mL) when receiving the currently recommended 800 IU/day vitamin D. This proposal is for exploratory research on the use of a wide range of oral vitamin D3 doses in frail elderly living in controlled living environments.

Detailed Description

The investigators will determine the dose response relationship of circulating total and unbound 25-OH vitamin D3 to supplemental vitamin D3 at daily doses of 800 (currently recommended for the elderly), 2000, and 4000 IU or 50,000 IU/weekly in a randomized blinded investigation of 16 weeks duration. The investigators will also compare the efficacy of each dosing regimen in achieving 25-OH vitamin D levels \>20 ng/mL (50 nmol/L) and identify covariates that contribute to inter-individual variation in the dose response relationship. In patients with osteoporosis, relationships between unbound vs. total 25-OH on intact parathyroid hormone and a marker of bone resorption (beta-Ctx) will be analyzed. The investigators will also examine responses of inflammatory cytokines.

Note: as of April 8,2014, there will be no further enrollment in the 50,000 IU/weekly dose group

Study Timeline

• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Study Start: 2012-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-01-23
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-13
• Last Update Submitted: 2015-02-13
• Results First Posted: 2015-02-18
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• age over 65
• medically stable
• residing in long-term care or assisted living

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Exclusion Criteria

• hypercalcemia or high risk for hypercalcemia
• active cancer or malignancy other than non-melanoma skin cancer
• severe renal disease (eGFR <30 ml/mkin/M2)
• small bowel resection or intestinal bypass surgery
• hyperparathyroidism
• granulomatous disease
• clinically unstable (changes in medications or diagnoses within a month, hospitalizations, within 6 months)
• allergy to vitamin D

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2000 IU/day D3	D3 2000 IU/day	D3 2000 IU/day
vitamin D3 800 IU/day	vitamin D3 800 IU/day	recommended daily dosage of 800 IU/day D3
vitamin D3 4000 IU/day	D3 4000 IU/day	D3 4000 IU/day
50,000 IU/week D3	D3 50,000 IU weekly	D3 50,000 IU weekly

Primary Outcome Measures

Name	Time	Method
Total 25-OH Vitamin D3 Level	16 weeks	circulating total 25-OH vitamin D concentration

Secondary Outcome Measures

Name	Time	Method
Free 25-OH Vitamin D3	16 weeks	circulating free 25-OH vitamin D3 concentration

Trial Locations

Locations (1)

University of California; 🇺🇸 San Francisco, California, United States