Optimizing Vitamin D in the Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Optimizing Vitamin D in the Elderly

Conditions
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Deficiency of Vitamin D3

Intervention / Treatment
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* Dietary Supplement: D3 2000 IU/day
* Dietary Supplement: D3 4000 IU/day
* Dietary Supplement: D3 50,000 IU weekly
* Dietary Supplement: vitamin D3 800 IU/day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D3 800 IU/day<br>recommended daily dosage of 800 IU/day D3 | Dietary Supplement: vitamin D3 800 IU/day<br>* vitamin D3 800 IU/day<br>* Other names: cholecalciferol;|
| Experimental: 2000 IU/day D3<br>D3 2000 IU/day | Dietary Supplement: D3 2000 IU/day<br>* 2000 IU/day D3<br>* Other names: cholecalciferol;|
| Experimental: vitamin D3 4000 IU/day<br>D3 4000 IU/day | Dietary Supplement: D3 4000 IU/day<br>* vitamin D3 4000 IU/day<br>* Other names: cholecalciferol;|
| Experimental: 50,000 IU/week D3<br>D3 50,000 IU weekly | Dietary Supplement: D3 50,000 IU weekly<br>* vitamin D3 50,000 IU/week<br>* Other names: cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D3, D3, cholecalciferol, 25-OH vitamin D, elderly, nursing home resident