Optimizing Vitamin D in the Elderly

This study is currently recruiting participants.
Verified April 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01554241
First received: March 12, 2012
Last updated: April 8, 2014
Last verified: April 2014

March 12, 2012
April 8, 2014
September 2012
August 2014   (final data collection date for primary outcome measure)
Total 25-OH vitamin D3 level [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
circulating total 25-OH vitamin D concentration
Same as current
Complete list of historical versions of study NCT01554241 on ClinicalTrials.gov Archive Site
Free 25-OH vitamin D3 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
circulating free 25-OH vitamin D3 concentration
Same as current
Not Provided
Not Provided
 
Optimizing Vitamin D in the Elderly
Optimizing Vitamin D in the Elderly

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Deficiency of Vitamin D3
  • Dietary Supplement: D3 2000 IU/day
    2000 IU/day D3
    Other Name: cholecalciferol
  • Dietary Supplement: D3 4000 IU/day
    vitamin D3 4000 IU/day
    Other Name: cholecalciferol
  • Dietary Supplement: D3 50,000 IU weekly
    vitamin D3 50,000 IU/week
    Other Name: cholecalciferol
  • Dietary Supplement: vitamin D3 800 IU/day
    vitamin D3 800 IU/day
    Other Name: cholecalciferol
  • Experimental: vitamin D3 800 IU/day
    recommended daily dosage of 800 IU/day D3
    Intervention: Dietary Supplement: vitamin D3 800 IU/day
  • Experimental: 2000 IU/day D3
    D3 2000 IU/day
    Intervention: Dietary Supplement: D3 2000 IU/day
  • Experimental: vitamin D3 4000 IU/day
    D3 4000 IU/day
    Intervention: Dietary Supplement: D3 4000 IU/day
  • Experimental: 50,000 IU/week D3
    D3 50,000 IU weekly
    Intervention: Dietary Supplement: D3 50,000 IU weekly
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
280
September 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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
Both
65 Years and older
No
Contact: Janice B Schwartz, MD (415) 406-1573 Janice.schwartz@ucsf.edu
United States
 
NCT01554241
DinNH2012, 1R21AG04166001-A1, additional funder
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Janice B Schwartz, MD University of California, San Francisco
University of California, San Francisco
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP