Replenishing and Maintaining Vitamin D Status in Older Adults in Residential Care Facilities in NI
Primary Purpose
Vitamin D Deficiency
Status
Suspended
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
3200IU Vitamin D3 per day for 8 weeks
20,000IU Vitamin D3 per week for 8 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Deficiency, Bone Health, Generic Health Relevance, Musculoskeletal Health, Intervention
Eligibility Criteria
Inclusion Criteria:
- Currently residing (≥1 month) within residential care facilities in Northern Ireland and who have previously undertaken the observation study (full title: A cross-sectional analysis of vitamin D status and bone health of older adults within residential care facilities in Northern Ireland) and have been identified as vitamin D deficient.
Exclusion Criteria:
- Participants will be excluded from the study if by the judgement of the consultant rheumatologist that they have very abnormal bone or vitamin D metabolism due to conditions such as end stage renal failure or bone metastases.
Sites / Locations
- Western Health and Social Care Trust Care Home facilities
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Weekly Vitamin D group
Daily Vitamin D group
Arm Description
Outcomes
Primary Outcome Measures
Vitamin D status
Plasma 25(OH)D status analysis by Liquid Chromatography / Mass Spec (LC/MS)
Secondary Outcome Measures
Osteocalcin concentration
Bone turnover marker
Bone-specific alkaline phosphatase concentration
Bone turnover marker
Full Information
NCT ID
NCT04395638
First Posted
May 11, 2020
Last Updated
May 19, 2020
Sponsor
University of Ulster
Collaborators
Western Health and Social Care Trust
1. Study Identification
Unique Protocol Identification Number
NCT04395638
Brief Title
Replenishing and Maintaining Vitamin D Status in Older Adults in Residential Care Facilities in NI
Official Title
Replenishing and Maintaining Vitamin D Status in Deficient Older Adults in Residential Care Facilities in Northern Ireland
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Suspended
Why Stopped
COVID-19 study status being reviewed on an ongoing basis.
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
Collaborators
Western Health and Social Care Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The vitamin D status of older adults in residential care facilities in Northern Ireland (NI) is currently unknown. An observation study is currently being carried out by Ulster University and the Western Health & Social Care Trust (WHSCT) to provide data on the prevalence of vitamin-D deficiency among older adults within residential care facilities in NI. It is expected that some 40% of the cohort will be deficient in vitamin D and will require immediate replenishment of vitamin D status. Therefore, as a follow up to the observational study, an intervention study will be conducted, where participants identified as vitamin D deficient (25(OH)D) status <30nmol/L (cut-off currently used by the WHSCT will be re-contacted and provided with a vitamin D supplement. The aim of this study is to investigate the dose and duration of vitamin D supplementation that is required to replenish and maintain vitamin D status in older adults with vitamin D deficiency within residential care facilities. Participants will be randomly assigned to receive one of two supplementation regimes: 3200IU/day vitamin D3 or 20,000IU/week vitamin D3. Blood samples (no more than 20ml per appointment) will be taken at 4 different time points: week 0, week 2, week 4 and week 8. These two doses are routinely used in clinical practice for remedial supplementation of vitamin D and have been chosen based upon their availability from manufacturers of vitamin D supplements. Also, albeit these doses are currently routinely used to replenish vitamin D status little is known on how effective they are and how soon vitamin D status is optimised. Clinicians can only administer medication for the management of osteoporosis (e.g. bisphosphonates) once vitamin D status is optimised. Therefore, measurements will be taken every two weeks to establish response to the remedial supplementation. This project provides a unique opportunity to monitor the replenishment and maintenance of vitamin D status following remedial supplementation more regularly (at weeks 0,2,4,8) than would be done under standard National Health Service care. This does and duration of vitamin D required to replenish vitamin D deficiency in older adults is currently ambiguous within the literature and clinical care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D, Deficiency, Bone Health, Generic Health Relevance, Musculoskeletal Health, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Weekly Vitamin D group
Arm Type
Experimental
Arm Title
Daily Vitamin D group
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
3200IU Vitamin D3 per day for 8 weeks
Intervention Description
3200IU Vitamin D3 per day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
20,000IU Vitamin D3 per week for 8 weeks
Intervention Description
20,000IU Vitamin D3 per week for 8 weeks
Primary Outcome Measure Information:
Title
Vitamin D status
Description
Plasma 25(OH)D status analysis by Liquid Chromatography / Mass Spec (LC/MS)
Time Frame
Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
Secondary Outcome Measure Information:
Title
Osteocalcin concentration
Description
Bone turnover marker
Time Frame
Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
Title
Bone-specific alkaline phosphatase concentration
Description
Bone turnover marker
Time Frame
Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Currently residing (≥1 month) within residential care facilities in Northern Ireland and who have previously undertaken the observation study (full title: A cross-sectional analysis of vitamin D status and bone health of older adults within residential care facilities in Northern Ireland) and have been identified as vitamin D deficient.
Exclusion Criteria:
Participants will be excluded from the study if by the judgement of the consultant rheumatologist that they have very abnormal bone or vitamin D metabolism due to conditions such as end stage renal failure or bone metastases.
Facility Information:
Facility Name
Western Health and Social Care Trust Care Home facilities
City
Londonderry
State/Province
Co.Londonderry
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Replenishing and Maintaining Vitamin D Status in Older Adults in Residential Care Facilities in NI
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