Replenishing and Maintaining Vitamin D Status in Older Adults in Residential Care Facilities in NI

Vitamin D Deficiency Clinical Trial

Official title:

Replenishing and Maintaining Vitamin D Status in Deficient Older Adults in Residential Care Facilities in Northern Ireland

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04395638
• Other study ID #: 20/NI/0031
• Status: Suspended
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: May 2020
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• 3200IU Vitamin D3 per day for 8 weeks
3200IU Vitamin D3 per day for 8 weeks
• 20,000IU Vitamin D3 per week for 8 weeks
20,000IU Vitamin D3 per week for 8 weeks

Locations

Country	Name	City	State
United Kingdom	Western Health and Social Care Trust Care Home facilities	Londonderry	Co.Londonderry

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	Western Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Osteocalcin concentration	Bone turnover marker	Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
Secondary	Bone-specific alkaline phosphatase concentration	Bone turnover marker	Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention