Optimizing Vitamin D in the Elderly

February 13, 2015 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • cholecalciferol
Experimental: 2000 IU/day D3
D3 2000 IU/day
Dietary supplement: D3 2000 IU/day
2000 IU/day D3
Other Names:
  • cholecalciferol
Experimental: vitamin D3 4000 IU/day
D3 4000 IU/day
Dietary supplement: D3 4000 IU/day
vitamin D3 4000 IU/day
Other Names:
  • 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 Names:
  • cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total 25-OH Vitamin D3 Level
Time Frame: 16 weeks
circulating total 25-OH vitamin D concentration
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free 25-OH Vitamin D3
Time Frame: 16 weeks
circulating free 25-OH vitamin D3 concentration
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Janice B Schwartz, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 13, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DinNH2012
  • 1R21AG04166001-A1 (Other Grant/Funding Number: National Institute on Aging)
  • additional funder (Other Grant/Funding Number: 1R21AG04166001-A1 Office of Dietary Supplements)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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