Optimizing Vitamin D in the Elderly

University of California San Francisco (UCSF)

Status: Completed

Conditions: Deficiency of Vitamin D3

Treatments: Dietary Supplement: D3 4000 IU/day; Dietary Supplement: vitamin D3 800 IU/day; Dietary Supplement: D3 2000 IU/day; Dietary Supplement: D3 50,000 IU weekly

Study type: Interventional

Funder types: Other

Identifiers

NCT01554241

DinNH2012

1R21AG04166001-A1 (Other Grant/Funding Number)

additional funder (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 86 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 4 patient groups

vitamin D3 800 IU/day

Experimental group

Description:

recommended daily dosage of 800 IU/day D3

Treatment:

Dietary Supplement: vitamin D3 800 IU/day

2000 IU/day D3

Experimental group

Description:

D3 2000 IU/day

Treatment:

Dietary Supplement: D3 2000 IU/day

vitamin D3 4000 IU/day

Experimental group

Description:

D3 4000 IU/day

Treatment:

Dietary Supplement: D3 4000 IU/day

50,000 IU/week D3

Experimental group

Description:

D3 50,000 IU weekly

Treatment:

Dietary Supplement: D3 50,000 IU weekly