Optimizing Vitamin D in the Elderly

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014