Skip to main content
OpenTrials
Completed

NCT Number: NCT01554241

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California

San Francisco, California, 94143, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D3 2000 IU/day

Dietary Supplement

2000 IU/day D3

Other names: cholecalciferol

D3 4000 IU/day

Dietary Supplement

vitamin D3 4000 IU/day

Other names: cholecalciferol

D3 50,000 IU weekly

Dietary Supplement

vitamin D3 50,000 IU/week

Other names: cholecalciferol

vitamin D3 800 IU/day

Dietary Supplement

vitamin D3 800 IU/day

Other names: cholecalciferol

Primary outcomes

  1. Total 25-OH Vitamin D3 Level

    Time frame: 16 weeks

    circulating total 25-OH vitamin D concentration

Secondary outcomes

  1. Free 25-OH Vitamin D3

    Time frame: 16 weeks

    circulating free 25-OH vitamin D3 concentration

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2012
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.