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

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

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.

Study Overview

• Status: Suspended
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: 20,000IU Vitamin D3 per week for 8 weeks; Dietary supplement: 3200IU Vitamin D3 per day for 8 weeks

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Co.Londonderry
    • Londonderry, Co.Londonderry, United Kingdom
      • Western Health and Social Care Trust Care Home facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Weekly Vitamin D group	Dietary supplement: 20,000IU Vitamin D3 per week for 8 weeks; 20,000IU Vitamin D3 per week for 8 weeks
EXPERIMENTAL: Daily Vitamin D group	Dietary supplement: 3200IU Vitamin D3 per day for 8 weeks; 3200IU Vitamin D3 per day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: Western Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): February 28, 2021
• Study Completion (ANTICIPATED): February 28, 2021

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (ACTUAL): May 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Vitamin D; Intervention; Deficiency; Bone Health; Generic Health Relevance; Musculoskeletal Health
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 20/NI/0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No