Vitamin D DeficiencyPhase 4NCT01437696
How Much Vitamin D is Required to be Protective Against Deficiency During the Winter Months?
A Phase 4 study testing Vitamin D in people with Vitamin D Deficiency, run by McGill University at 1 site in Canada.
Trial summary
Vitamin D is essential to bone health. In Canada, it is obtained by sunlight exposure of the skin (between April and October) or by a few foods such as fatty fish, eggs or fortified milk and margarine. Read more about this study
- Who is it for?
- Ages 70 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All Veterans over the age of 70 years will be invited to participate given selection and exclusion criteria. Level 1, 2 and 3 care will comprise the recruitment pool. These levels of care permit such investigation and do not include those in palliative conditions.
- Individuals with chronic diseases will be permitted to participate as long as the disease is not end-stage (ie prognosis of more than 4 months).
- Not excluding co-morbidities or poor cognition is consistent with the work of others in the area.
- Lastly combined oral and enteral feeding modes will be included since the majority quickly transition to foods but some do take a meal-replacement/liquid supplement.
Who cannot join
- End-stage renal disease due to altered vitamin D metabolism and use of vitamin D analogues
- End-stage liver disease
- Untreated hyperparathyroid conditions such as cancer and metabolic bone disease except for osteoporosis and osteomalacia
- Any condition that requires enteral feeding alone as feeding route will be excluded since this oral intake, even if only partial, is a critical measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Much Vitamin D is Required to be Protective Against Deficiency During the Winter Months? - An Investigation in Veterans Living at Ste-Anne's Hospital
Vitamin D is essential to bone health. In Canada, it is obtained by sunlight exposure of the skin (between April and October) or by a few foods such as fatty fish, eggs or fortified milk and margarine. This study has 3 main goals which are to determine if Veteran's have enough vitamin D stored in their body, if adding a supplement of 2000 IU/d is enough to correct low vitamin D stores and, if specially formulated foods using an approved vitamin D supplement, are appropriate to maintain vitamin D stores in relation with functional and cognitive status. Initially, a 2000 IU supplement of vitamin D will be provided for 8 weeks. After this period, the participants will be randomly separated into 3 groups (Group A, B or C) for a period of 24 weeks. Group A will receive their usual menu. Group B will receive their usual menu with 1 portion of food containing 500 IU of added vitamin D. Group C will receive their usual menu with 1 portion of food containing 1000 IU of added vitamin D. Food intake will be assessed every 8 weeks and blood samples will be taken every 4 weeks to monitor change in blood concentration of vitamin D and other indicators of bone health. The investigators will document weight and height, hand grip strength, the mid-arm and mid-calf circumferences, the capacity to perform activities of daily living, the number of prescriptions and changes in health condition. The investigators will also take an X-ray the tibia and upper arm to document the amount and quality of bones in those regions. A total of 60 veterans of Ste-Anne's Hospital will participate in this study. Knowing more about vitamin D status and intake will help in confirming the required vitamin D recommendations for the elderly men living in long-term care institutions.
Read the detailed description
The main objectives of the proposed 2 phase-protocol in aged Canadian veterans (n=60) are to evaluate the impact of 2000 IU/day of vitamin D3 supplementation (tablets or liquid form) on correcting low vitamin D status and the associated impact on biochemistry, bone health markers and markers of inflammation in a Fall period (Before and After, 8 weeks) and, 2) evaluate which food-based supplementation will maintain vitamin D3 status thereafter from winter through spring by measuring serum 25(OH)D concentration following intake of vitamin D delivered (with liquid form vitamin D3) using foods as the vehicle providing an additional 1000 IU/day or 500 IU/day compared to regular meals offered at Ste-Anne's Hospital (SAH) (Randomized Controlled Trial, 3 groups, 24 weeks). Anthropometry (weight, height, BMI, mid-arm and mid-calf circumferences), grip strength, biochemical markers of bone health (25(OH)D, PTH, calcium, ionized calcium and phosphate), assessments of cognitive and functional status (Mini-Mental State Evaluation, Frail Elderly Functional Assessment, Physiotherapy Functional Mobility Profile and Pain Assessment Checklist) as well as volumetric bone mineral density using peripheral quantitative computed tomography (pQCT) will be gathered.
The long-term goal of the research program is to use novel food-delivery systems and approaches to enhancing vitamin D intake that meets the needs of this population. For years, medications have been delivered through foods but few studies have applied this to natural health products such as vitamin D. In chronic care, the number of prescription pills is high often 13 or more not accounting for multiple administrations over a day. Further documentation of health related indicators such as capacity to perform daily activities and chronic pain intensity would relate to quality of life and improve our understanding of vitamin D in more than bone health related issues. The reality of long-term care facilities (financial, human and material resources) needs to be addressed for the newly developed delivery modes to meet the needs of these residents and the projected increase in care required for our aging Canadian population. Large scale interventions will need to take place to give more insight on efficacy and efficiency of this new food delivery approach.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D, placebo
- Keywords
- Aging, Vitamin D, Bone health, Inflammation, Men
- Medical subject headings
- Vitamin D Deficiency, Inflammation, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
A liquid cholecalciferol at a dosage of 500IU will be added to a specific food and provided to the participants once a day for 24 weeks.
Vitamin DDietary supplement
A liquid cholecalciferol at a dosage of 1000IU will be added to a specific food and provided to the participants once a day for 24 weeks.
placeboOther
No liquid cholecalciferol will be added to the food.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D fortified food 500 IU | Experimental | One portion of a specific food item will be provided each day. 500 IU Vitamin D added. Receives: Dietary Supplement: Vitamin D |
| Vitamin D fortified food 1000 IU | Experimental | One portion of a specific food item will be provided each day. 1000 IU Vitamin D added. Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | One portion of a specific food item will be provided each day. No vitamin D added. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 25(OH)D plasma concentrations
Fasted morning blood samples will be taken monthly for assessment of 25(OH)D plasma concentrations.
Measured: Baseline and following 8 weeks of the observation phase. Also following 1, 2, 3, 4, 5 and 6 months of the active supplementation phase.
Changes in Vitamin D intake from foods and supplements
Using food records, vitamin intake will be assessed for 3 days. The records will be collected by a registered dietitian.
Measured: Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.
Secondary outcomes (6)
Change in bone mineral density
Using peripheral quantitative computed tomography (pQCT) bone mineral density will be assessed for the radius and tibia.
Measured: Baseline and following 6 months of the active supplementation phase (32 week timepoint).
Changes in functional mobility
Functional mobility will be assessed using grip strength, frail elderly functional assessment (FEFA) and physiotherapy functional mobility profile (PFMP). The assessments will be conducted by the doctoral student and a physiotherapist.
Measured: Baseline and following 32 weeks of study involvement
Change in chronic pain over time
Chronic pain will be assessed using PACSLAC: Pain Assessment Checklist for Seniors with Limited Ability to Communicate.
Measured: Baseline and following 8 weeks of the observation phase. Also following 6 months of the active supplementation phase (32 week timepoint).
Changes in biochemistry measurements during the study period
Fasted morning blood sample will be taken to assess calcium, ionized calcium, phosphate, glucose, sodium, potassium, albumin, hemoglobin, and total protein.
Measured: Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.
Changes in inflammatory markers and bone metabolism markers
Fasted morning blood sample will be taken to assess inflammatory markers: CRP, IL-6, IL-12, IL-14, and TNF alpha. Bone metabolism will be assessed by CTX and osteocalcin.
Measured: Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.
Change in PTH
Fasted morning blood samples will be taken monthly for assessment of PTH plasma concentrations.
Measured: Baseline and following 8 weeks of the observation phase. Also following 1, 2, 3, 4, 5 and 6 months of the active supplementation phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Hope Weiler, McGill University
- Investigators
- Hope A Weiler, PhD, RD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437696
- Sponsor's protocol ID
- HW-11-02
- Status last verified
- Sep 2014
- First submitted
- 15 Sep 2011
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Much Vitamin D is Required to be Protective Against Deficiency During the Winter Months? - An Investigation in Veterans Living at Ste-Anne's Hospital
- ClinicalTrials.gov ID
- NCT01437696
- Acronym / sponsor ID
- HW-11-02
- Conditions
- Vitamin D Deficiency
- Keywords
- Aging, Vitamin D, Bone health, Inflammation, Men
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D is essential to bone health. In Canada, it is obtained by sunlight exposure of the skin (between April and October) or by a few foods such as fatty fish, eggs or fortified milk and margarine. This study has 3 main goals which are to determine if Veteran's have enough vitamin D stored in their body, if adding a supplement of 2000 IU/d is enough to correct low vitamin D stores and, if specially formulated foods using an approved vitamin D supplement, are appropriate to maintain vitamin D stores in relation with functional and cognitive status. Initially, a 2000 IU supplement of vitamin D will be provided for 8 weeks. After this period, the participants will be randomly separated into 3 groups (Group A, B or C) for a period of 24 weeks. Group A will receive their usual menu. Group B will receive their usual menu with 1 portion of food containing 500 IU of added vitamin D. Group C will receive their usual menu with 1 portion of food containing 1000 IU of added vitamin D. Food intake will be assessed every 8 weeks and blood samples will be taken every 4 weeks to monitor change in blood concentration of vitamin D and other indicators of bone health. The investigators will document weight and height, hand grip strength, the mid-arm and mid-calf circumferences, the capacity to perform activities of daily living, the number of prescriptions and changes in health condition. The investigators will also take an X-ray the tibia and upper arm to document the amount and quality of bones in those regions. A total of 60 veterans of Ste-Anne's Hospital will participate in this study. Knowing more about vitamin D status and intake will help in confirming the required vitamin D recommendations for the elderly men living in long-term care institutions.
Detailed description
The main objectives of the proposed 2 phase-protocol in aged Canadian veterans (n=60) are to evaluate the impact of 2000 IU/day of vitamin D3 supplementation (tablets or liquid form) on correcting low vitamin D status and the associated impact on biochemistry, bone health markers and markers of inflammation in a Fall period (Before and After, 8 weeks) and, 2) evaluate which food-based supplementation will maintain vitamin D3 status thereafter from winter through spring by measuring serum 25(OH)D concentration following intake of vitamin D delivered (with liquid form vitamin D3) using foods as the vehicle providing an additional 1000 IU/day or 500 IU/day compared to regular meals offered at Ste-Anne's Hospital (SAH) (Randomized Controlled Trial, 3 groups, 24 weeks). Anthropometry (weight, height, BMI, mid-arm and mid-calf circumferences), grip strength, biochemical markers of bone health (25(OH)D, PTH, calcium, ionized calcium and phosphate), assessments of cognitive and functional status (Mini-Mental State Evaluation, Frail Elderly Functional Assessment, Physiotherapy Functional Mobility Profile and Pain Assessment Checklist) as well as volumetric bone mineral density using peripheral quantitative computed tomography (pQCT) will be gathered.
The long-term goal of the research program is to use novel food-delivery systems and approaches to enhancing vitamin D intake that meets the needs of this population. For years, medications have been delivered through foods but few studies have applied this to natural health products such as vitamin D. In chronic care, the number of prescription pills is high often 13 or more not accounting for multiple administrations over a day. Further documentation of health related indicators such as capacity to perform daily activities and chronic pain intensity would relate to quality of life and improve our understanding of vitamin D in more than bone health related issues. The reality of long-term care facilities (financial, human and material resources) needs to be addressed for the newly developed delivery modes to meet the needs of these residents and the projected increase in care required for our aging Canadian population. Large scale interventions will need to take place to give more insight on efficacy and efficiency of this new food delivery approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D fortified food 500 IU | Experimental | Dietary Supplement: Vitamin DOne portion of a specific food item will be provided each day. 500 IU Vitamin D added. |
| Vitamin D fortified food 1000 IU | Experimental | Dietary Supplement: Vitamin DOne portion of a specific food item will be provided each day. 1000 IU Vitamin D added. |
| Placebo | Placebo comparator | Other: placeboOne portion of a specific food item will be provided each day. No vitamin D added. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- All Veterans over the age of 70 years will be invited to participate given selection and exclusion criteria. Level 1, 2 and 3 care will comprise the recruitment pool. These levels of care permit such investigation and do not include those in palliative conditions.
- Individuals with chronic diseases will be permitted to participate as long as the disease is not end-stage (ie prognosis of more than 4 months).
- Not excluding co-morbidities or poor cognition is consistent with the work of others in the area.
- Lastly combined oral and enteral feeding modes will be included since the majority quickly transition to foods but some do take a meal-replacement/liquid supplement.
Key exclusion criteria (4 listed)
- End-stage renal disease due to altered vitamin D metabolism and use of vitamin D analogues
- End-stage liver disease
- Untreated hyperparathyroid conditions such as cancer and metabolic bone disease except for osteoporosis and osteomalacia
- Any condition that requires enteral feeding alone as feeding route will be excluded since this oral intake, even if only partial, is a critical measurement.
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 |
|---|---|---|
| Vitamin DA liquid cholecalciferol at a dosage of 500IU will be added to a specific food and provided to the participants once a day for 24 weeks. | Dietary supplement | Vitamin D fortified food 500 IU |
| Vitamin DA liquid cholecalciferol at a dosage of 1000IU will be added to a specific food and provided to the participants once a day for 24 weeks. | Dietary supplement | Vitamin D fortified food 1000 IU |
| placeboNo liquid cholecalciferol will be added to the food. | Other | Placebo |
Primary outcome
Change in 25(OH)D plasma concentrations
Time frame: Baseline and following 8 weeks of the observation phase. Also following 1, 2, 3, 4, 5 and 6 months of the active supplementation phase.
Fasted morning blood samples will be taken monthly for assessment of 25(OH)D plasma concentrations.
Changes in Vitamin D intake from foods and supplements
Time frame: Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.
Using food records, vitamin intake will be assessed for 3 days. The records will be collected by a registered dietitian.
6 secondary outcomes
Change in bone mineral density
Time frame: Baseline and following 6 months of the active supplementation phase (32 week timepoint).
Changes in functional mobility
Time frame: Baseline and following 32 weeks of study involvement
Change in chronic pain over time
Time frame: Baseline and following 8 weeks of the observation phase. Also following 6 months of the active supplementation phase (32 week timepoint).
Changes in biochemistry measurements during the study period
Time frame: Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.
Changes in inflammatory markers and bone metabolism markers
Time frame: Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.
Change in PTH
Time frame: Baseline and following 8 weeks of the observation phase. Also following 1, 2, 3, 4, 5 and 6 months of the active supplementation phase.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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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.
Hope A Weiler, PhD, RD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Vitamin D Deficiency, run by McGill University at 1 site in Canada.
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 4 inclusion and 4 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 5 Sep 2014. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in 25(OH)D plasma concentrations (time frame: Baseline and following 8 weeks of the observation phase. Also following 1, 2, 3, 4, 5 and 6 months of the active supplementation phase.). The study lists 2 primary outcomes in all. 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 5 Sep 2014.