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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG04166001-A1 | Other Grant/Funding Number | National Institute on Aging | |
| additional funder | Other Grant/Funding Number | 1R21AG04166001-A1 Office of Dietary Supplements |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D3 800 IU/day | Experimental | recommended daily dosage of 800 IU/day D3 |
|
| 2000 IU/day D3 | Experimental | D3 2000 IU/day |
|
| vitamin D3 4000 IU/day | Experimental | D3 4000 IU/day |
|
| 50,000 IU/week D3 | Experimental | D3 50,000 IU weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D3 2000 IU/day | Dietary Supplement | 2000 IU/day D3 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total 25-OH Vitamin D3 Level | circulating total 25-OH vitamin D concentration | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Free 25-OH Vitamin D3 | circulating free 25-OH vitamin D3 concentration | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice B Schwartz, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | San Francisco | California | 94143 | United States |
Following participant consent/enrollment, 4 were ineligible due to clinical instability or abnormal laboratory tests and one withdrew consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 800 IU/Day | recommended daily dosage of 800 IU/day D3 vitamin D3 800 IU/day: vitamin D3 800 IU/day |
| FG001 | 2000 IU/Day D3 | D3 2000 IU/day D3 2000 IU/day: 2000 IU/day D3 |
| FG002 | Vitamin D3 4000 IU/Day | D3 4000 IU/day D3 4000 IU/day: vitamin D3 4000 IU/day |
| FG003 | 50,000 IU/Week D3 | D3 50,000 IU weekly D3 50,000 IU weekly: vitamin D3 50,000 IU/week |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Elderly (>65 yr) clinically stable long-term stay nursing home residents with no contraindications or allergy to D, osteoporosis or a history of fractures and receiving over 800 IU/day D, treatment for severe D deficiency or investigational agent in the prior six months on no D or had stable D doses for over two months .
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3 800 IU/Day | recommended daily dosage of 800 IU/day D3 vitamin D3 800 IU/day: vitamin D3 800 IU/day |
| BG001 | 2000 IU/Day D3 | D3 2000 IU/day D3 2000 IU/day: 2000 IU/day D3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total 25-OH Vitamin D3 Level | circulating total 25-OH vitamin D concentration | Posted | Mean | Standard Deviation | ng/mL | 16 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D3 800 IU/Day | recommended daily dosage of 800 IU/day D3 vitamin D3 800 IU/day: vitamin D3 800 IU/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| serious | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janice B.Schwartz, M.D., Professor of Medicine | University of California, San Francisco | (415) 406-1573 | janice.schwartz@ucsf.edu |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| D3 4000 IU/day | Dietary Supplement | vitamin D3 4000 IU/day |
|
|
| D3 50,000 IU weekly | Dietary Supplement | vitamin D3 50,000 IU/week |
|
|
| vitamin D3 800 IU/day | Dietary Supplement | vitamin D3 800 IU/day |
|
|
| protocol specified renal stone |
|
| protocol specified change in eGFR |
|
| Withdrawal by Subject |
|
| BG002 | Vitamin D3 4000 IU/Day | D3 4000 IU/day D3 4000 IU/day: vitamin D3 4000 IU/day |
| BG003 | 50,000 IU/Week D3 | D3 50,000 IU weekly D3 50,000 IU weekly: vitamin D3 50,000 IU/week |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | 50,000 IU/Week D3 | D3 50,000 IU weekly D3 50,000 IU weekly: vitamin D3 50,000 IU/week |
|
|
|
| Secondary | Free 25-OH Vitamin D3 | circulating free 25-OH vitamin D3 concentration | Posted | Mean | Standard Deviation | pg/mL | 16 weeks |
|
|
|
|
| 7 |
| 23 |
| 1 |
| 23 |
| EG001 | 2000 IU/Day D3 | D3 2000 IU/day D3 2000 IU/day: 2000 IU/day D3 | 2 | 20 | 1 | 20 |
| EG002 | Vitamin D3 4000 IU/Day | D3 4000 IU/day D3 4000 IU/day: vitamin D3 4000 IU/day | 1 | 24 | 0 | 24 |
| EG003 | 50,000 IU/Week D3 | D3 50,000 IU weekly D3 50,000 IU weekly: vitamin D3 50,000 IU/week | 3 | 14 | 0 | 14 |
| flu/pneumonia/sepsis | Infections and infestations | Systematic Assessment |
|
| renal complication | Renal and urinary disorders | Systematic Assessment |
|
| hyperbilirubinemia | Hepatobiliary disorders | Systematic Assessment | biliary obstruction |
|
| fall + fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| chest pain | Vascular disorders | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
Bonferroni/Dunn adjustment
| =0.47 |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA | Bonferroni/Dunn adjustment | <.002 | 2-Sided | No | Superiority or Other |
| ANOVA | Bonferroni/Dunn adjustment | <.0001 | 2-Sided | No | Superiority or Other |
| ANOVA | Bonferroni/Dunn adjustment | <.02 | 2-Sided | No | Superiority or Other |
| ANOVA | Bonferroni/Dunn adjustment | <.0001 | 2-Sided | No | Superiority or Other |
| ANOVA | Bonferroni/Dunn adjustment | <.0003 | 2-Sided | No | Superiority or Other |