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COVID-19 study status being reviewed on an ongoing basis.
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| Name | Class |
|---|---|
| Western Health and Social Care Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly Vitamin D group | Experimental |
| |
| Daily Vitamin D group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3200IU Vitamin D3 per day for 8 weeks | Dietary Supplement | 3200IU Vitamin D3 per day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D status | Plasma 25(OH)D status analysis by Liquid Chromatography / Mass Spec (LC/MS) | Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Osteocalcin concentration | Bone turnover marker | Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention |
| Bone-specific alkaline phosphatase concentration | Bone turnover marker |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Health and Social Care Trust Care Home facilities | Londonderry | Co.Londonderry | United Kingdom |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| 20,000IU Vitamin D3 per week for 8 weeks | Dietary Supplement | 20,000IU Vitamin D3 per week for 8 weeks |
|
| Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention |
| D009750 |
| Nutritional and Metabolic Diseases |