N/A
N=81
Optimizing Vitamin D in the Elderly
Deficiency of Vitamin D3
Bottom Line
View on ClinicalTrials.gov: NCT01554241 ↗Enrolled (actual)
81
Serious AEs
16.1%
Results posted
Feb 2015
Primary outcome: Primary: Total 25-OH Vitamin D3 Level — 33; 34; 43; 61 ng/mL — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- D3 2000 IU/day (Dietary_supplement); D3 4000 IU/day (Dietary_supplement); D3 50,000 IU weekly (Dietary_supplement); vitamin D3 800 IU/day (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total 25-OH Vitamin D3 Level |
33; 34; 43; 61 | <.0001 sig |
| SECONDARY Free 25-OH Vitamin D3 |
8.7; 9.5; 12.2; 16.8 | <.0001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01554241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.