Optimizing Vitamin D in the Elderly

Deficiency of Vitamin D3 Clinical Trial

Official title:

Optimizing Vitamin D in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554241
• Other study ID #: DinNH2012
• Secondary ID: 1R21AG04166001-A
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: February 13, 2015
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Deficiency of Vitamin D3

Intervention

Dietary Supplement:
• D3 2000 IU/day
2000 IU/day D3
• D3 4000 IU/day
vitamin D3 4000 IU/day
• D3 50,000 IU weekly
vitamin D3 50,000 IU/week
• vitamin D3 800 IU/day
vitamin D3 800 IU/day

Locations

Country	Name	City	State
United States	University of California	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total 25-OH Vitamin D3 Level	circulating total 25-OH vitamin D concentration	16 weeks	No
Secondary	Free 25-OH Vitamin D3	circulating free 25-OH vitamin D3 concentration	16 weeks	No