How Much Vitamin D is Required to be Protective Against Deficiency During the Winter Months?

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437696
• Other study ID #: HW-11-02
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2011
• Last updated: September 4, 2014
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
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 D
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.

Other:
• placebo
No liquid cholecalciferol will be added to the food.

Locations

Country	Name	City	State
Canada	Ste. Anne's Hospital	Ste. Anne-de-Bellevue	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 25(OH)D plasma concentrations	Fasted morning blood samples will be taken monthly for assessment of 25(OH)D plasma concentrations.	Baseline and following 8 weeks of the observation phase. Also following 1, 2, 3, 4, 5 and 6 months of the active supplementation phase.	Yes
Primary	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.	Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.	No
Secondary	Change in bone mineral density	Using peripheral quantitative computed tomography (pQCT) bone mineral density will be assessed for the radius and tibia.	Baseline and following 6 months of the active supplementation phase (32 week timepoint).	No
Secondary	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.	Baseline and following 32 weeks of study involvement	No
Secondary	Change in chronic pain over time	Chronic pain will be assessed using PACSLAC: Pain Assessment Checklist for Seniors with Limited Ability to Communicate.	Baseline and following 8 weeks of the observation phase. Also following 6 months of the active supplementation phase (32 week timepoint).	No
Secondary	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.	Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.	Yes
Secondary	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.	Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.	No
Secondary	Change in PTH	Fasted morning blood samples will be taken monthly for assessment of PTH plasma concentrations.	Baseline and following 8 weeks of the observation phase. Also following 1, 2, 3, 4, 5 and 6 months of the active supplementation phase.	Yes