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
  Purpose

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.


Condition Intervention
Deficiency of Vitamin D3
Dietary Supplement: D3 2000 IU/day
Dietary Supplement: D3 4000 IU/day
Dietary Supplement: D3 50,000 IU weekly
Dietary Supplement: vitamin D3 800 IU/day

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Optimizing Vitamin D in the Elderly

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Total 25-OH vitamin D3 level [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    circulating total 25-OH vitamin D concentration


Secondary Outcome Measures:
  • Free 25-OH vitamin D3 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    circulating free 25-OH vitamin D3 concentration


Estimated Enrollment: 280
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D3 800 IU/day
recommended daily dosage of 800 IU/day D3
Dietary Supplement: vitamin D3 800 IU/day
vitamin D3 800 IU/day
Other Name: cholecalciferol
Experimental: 2000 IU/day D3
D3 2000 IU/day
Dietary Supplement: D3 2000 IU/day
2000 IU/day D3
Other Name: cholecalciferol
Experimental: vitamin D3 4000 IU/day
D3 4000 IU/day
Dietary Supplement: D3 4000 IU/day
vitamin D3 4000 IU/day
Other Name: cholecalciferol
Experimental: 50,000 IU/week D3
D3 50,000 IU weekly
Dietary Supplement: D3 50,000 IU weekly
vitamin D3 50,000 IU/week
Other Name: cholecalciferol

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554241

Contacts
Contact: Janice B Schwartz, MD (415) 406-1573 Janice.schwartz@ucsf.edu

Locations
United States, California
University of California Recruiting
San Francisco, California, United States, 94143
Contact: Janice B Schwartz, MD    415-406-1573    Janice.schwartz@ucsf.edu   
Principal Investigator: Janice B Schwartz, M.D.         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Janice B Schwartz, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01554241     History of Changes
Other Study ID Numbers: DinNH2012, 1R21AG04166001-A1, additional funder
Study First Received: March 12, 2012
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
vitamin D3
D3
cholecalciferol
25-OH vitamin D
elderly
nursing home resident

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014