Deficiency of Vitamin D3NCT01554241
Optimizing Vitamin D in the Elderly
A study testing D3 2000 IU/day, D3 4000 IU/day and D3 50,000 IU weekly in people with Deficiency of Vitamin D3, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Deficiency of Vitamin D3
- What is being tested?
- D3 2000 IU/day, D3 4000 IU/day and D3 50,000 IU weekly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age over 65
- medically stable
- residing in long-term care or assisted living
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94143
About this study
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.
Read the 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
- Conditions
- Deficiency of Vitamin D3
- Being tested
- D3 2000 IU/day, D3 4000 IU/day, D3 50,000 IU weekly, vitamin D3 800 IU/day
- Keywords
- vitamin D3, D3, cholecalciferol, 25-OH vitamin D, elderly, nursing home resident
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D3 2000 IU/dayDietary supplement
Also called cholecalciferol
2000 IU/day D3
D3 4000 IU/dayDietary supplement
Also called cholecalciferol
vitamin D3 4000 IU/day
D3 50,000 IU weeklyDietary supplement
Also called cholecalciferol
vitamin D3 50,000 IU/week
vitamin D3 800 IU/dayDietary supplement
Also called cholecalciferol
vitamin D3 800 IU/day
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 800 IU/day | Experimental | recommended daily dosage of 800 IU/day D3 Receives: Dietary Supplement: vitamin D3 800 IU/day |
| 2000 IU/day D3 | Experimental | D3 2000 IU/day Receives: Dietary Supplement: D3 2000 IU/day |
| vitamin D3 4000 IU/day | Experimental | D3 4000 IU/day Receives: Dietary Supplement: D3 4000 IU/day |
| 50,000 IU/week D3 | Experimental | D3 50,000 IU weekly Receives: Dietary Supplement: D3 50,000 IU weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 25-OH Vitamin D3 Level
circulating total 25-OH vitamin D concentration
Measured: 16 weeks
Secondary outcomes (1)
Free 25-OH Vitamin D3
circulating free 25-OH vitamin D3 concentration
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deficiency of Vitamin D3Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice B Schwartz, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554241
- Sponsor's protocol ID
- DinNH2012
- Other IDs
- 1R21AG04166001-A1, additional funder
- Status last verified
- Feb 2015
- First submitted
- 12 Mar 2012
- Last updated
- 18 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Vitamin D in the Elderly
- ClinicalTrials.gov ID
- NCT01554241
- Acronym / sponsor ID
- DinNH2012
- Conditions
- Deficiency of Vitamin D3
- Keywords
- vitamin D3, D3, cholecalciferol, 25-OH vitamin D, elderly, nursing home resident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Posted 18 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 800 IU/day | Experimental | Dietary Supplement: vitamin D3 800 IU/dayrecommended daily dosage of 800 IU/day D3 |
| 2000 IU/day D3 | Experimental | Dietary Supplement: D3 2000 IU/dayD3 2000 IU/day |
| vitamin D3 4000 IU/day | Experimental | Dietary Supplement: D3 4000 IU/dayD3 4000 IU/day |
| 50,000 IU/week D3 | Experimental | Dietary Supplement: D3 50,000 IU weeklyD3 50,000 IU weekly |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age over 65
- medically stable
- residing in long-term care or assisted living
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D3 2000 IU/dayAlso: cholecalciferol2000 IU/day D3 | Dietary supplement | 2000 IU/day D3 |
| D3 4000 IU/dayAlso: cholecalciferolvitamin D3 4000 IU/day | Dietary supplement | vitamin D3 4000 IU/day |
| D3 50,000 IU weeklyAlso: cholecalciferolvitamin D3 50,000 IU/week | Dietary supplement | 50,000 IU/week D3 |
| vitamin D3 800 IU/dayAlso: cholecalciferolvitamin D3 800 IU/day | Dietary supplement | vitamin D3 800 IU/day |
Primary outcome
Total 25-OH Vitamin D3 Level
Time frame: 16 weeks
circulating total 25-OH vitamin D concentration
1 secondary outcome
Free 25-OH Vitamin D3
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice B Schwartz, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D3 2000 IU/day, D3 4000 IU/day and D3 50,000 IU weekly in people with Deficiency of Vitamin D3, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 25-OH Vitamin D3 Level (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.