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

NCT04395638 | Suspended

• 1 other identifier: 20/NI/0031
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D; Deficiency; Bone Health; Generic Health Relevance; Musculoskeletal Health; Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Osteocalcin concentration

  Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention

• Bone-specific alkaline phosphatase concentration

  Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention

Study Arms (2)

Weekly Vitamin D group

EXPERIMENTAL

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

Daily Vitamin D group

EXPERIMENTAL

Dietary Supplement: 3200IU Vitamin D3 per day for 8 weeks

Interventions

3200IU Vitamin D3 per day for 8 weeks DIETARY_SUPPLEMENT

3200IU Vitamin D3 per day for 8 weeks

Daily Vitamin D group

20,000IU Vitamin D3 per week for 8 weeks DIETARY_SUPPLEMENT

20,000IU Vitamin D3 per week for 8 weeks

Weekly Vitamin D group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead
• Western Health and Social Care Trust: collaborator

Study Sites (1)

Western Health and Social Care Trust Care Home facilities

Londonderry, Co.Londonderry, United Kingdom

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 20, 2020
• Study Start: September 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)