Optimizing Vitamin D in the Elderly
3 other identifiers
interventional
86
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
February 18, 2015
CompletedFebruary 18, 2015
February 1, 2015
2 years
March 12, 2012
January 23, 2015
February 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total 25-OH Vitamin D3 Level
circulating total 25-OH vitamin D concentration
16 weeks
Secondary Outcomes (1)
Free 25-OH Vitamin D3
16 weeks
Study Arms (4)
vitamin D3 800 IU/day
EXPERIMENTALrecommended daily dosage of 800 IU/day D3
2000 IU/day D3
EXPERIMENTALD3 2000 IU/day
vitamin D3 4000 IU/day
EXPERIMENTALD3 4000 IU/day
50,000 IU/week D3
EXPERIMENTALD3 50,000 IU weekly
Interventions
vitamin D3 4000 IU/day
vitamin D3 50,000 IU/week
vitamin D3 800 IU/day
Eligibility Criteria
You may qualify if:
- age over 65
- medically stable
- residing in long-term care or assisted living
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California
San Francisco, California, 94143, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Janice B.Schwartz, M.D., Professor of Medicine
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Janice B Schwartz, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 14, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
February 18, 2015
Results First Posted
February 18, 2015
Record last verified: 2015-02