Vitamin C 4 Care Homes

NCT05122481 | Withdrawn

• 2 other identifiers: 2-061-21296819
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Older people in care homes are one of the most vulnerable groups with respect to risk, morbidity and mortality of severe coronavirus disease-2019 (COVID-19). In the UK, almost half (47%) of all COVID-19 deaths occurred in care homes. The World Health Organization (WHO) has highlighted vitamin C as an adjunctive therapy with biological plausibility for people with severe COVID-19. Previous research has indicated that up to 40% of care home residents in the UK are deficient in vitamin C, an essential immune supportive nutrient. This is a 10-fold higher deficiency level than that reported in community dwelling older people in the UK government's National Diet and Nutrition Survey. Due to lack of robust pharmacokinetic data in older people, the intake required to optimise the vitamin C status of this cohort is not yet known and may be higher than that for healthy adults; some have estimated as high as 400 mg/d (the current UK recommended nutrient intake (RNI) or vitamin C is 40 mg/d, which is sufficient to prevent deficiency, but not enough for optimal/saturating vitamin C status). Thus, this pilot and feasibility study will assess the intake requirements of care home residents for optimal vitamin C status. The purpose is to provide essential data for a future clinical trial assessing the efficacy of optimal vitamin C supplementation for risk, severity, and duration of respiratory infections in this population who are at risk of such infections.

Conditions

Hypovitaminosis; Vitamin C Abnormal

Keywords

Vitamin C; Care home; Hypovitaminosis

Outcome Measures

Primary Outcomes (1)

• Number of participants reporting hypovitaminosis symptoms by end of study

  Any symptoms which participants report which are listed in vitamin C overdose signs and symptoms

  6 days

Secondary Outcomes (1)

• The feasibility of undertaking a study with this group of older people in a care home setting.

  2 months

Study Arms (1)

Care home residents

EXPERIMENTAL

On the test days, the participant will be asked to provide a urine sample before taking the supplement, this sample will be used as a baseline and assessed for Vitamin C and creatinine/protein and specific gravity, with the same testing strips as mentioned above. Once collected, the participant will be provided with a drink containing an increasing daily dose of vitamin C (0 - 500 mg). A second urine sample will then be collected approx. 3 - 4 hours later to assess the extent of vitamin C excretion in urine with an increase in vitamin C supplement. Another urine test strip will also be used to determine creatinine concentrations, the presence of albumin/protein, and specific gravity (to determine urine concentration). Up to 3 days will be allowed between daily testing to allow for long weekends, absences, illness, etc. Therefore, the participants are expected to complete the study within 4 weeks.

Dietary Supplement: Vitamin C

Interventions

Vitamin C DIETARY_SUPPLEMENT

Vitamin C (also known as ascorbic acid and ascorbate) is a vitamin found in various foods and sold as a dietary supplement.Vitamin C is a water-soluble vitamin, with dietary excesses not absorbed, and excesses in the blood rapidly excreted in the urine, so it exhibits remarkably low acute toxicity. More than one gram may cause indigestion, flatulence and stomach pain.

Also known as: Ascorbic Acid; Vit. C; ascorbate

Care home residents

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Resident in a care home
• Aged ≥65 years

You may not qualify if:

• Unable to give fully informed consent, e.g. due to severe dementia
• Any health conditions precluding collection of fresh urine samples (e.g. urinary catheter)
• Active (acute) respiratory infection
• Currently taking vitamin C containing supplements at greater than the recommended dietary intake (40 mg/d)

Sponsors & Collaborators

• University of Aberdeen: lead
• University of Otago: collaborator

Study Sites (1)

University of Aberdeen

Aberdeen, Aberdeen City, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Avitaminosis

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Randomized number allocation
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot dose-finding study comprising 20 older people ENRICH listed care home residents (aged 65+) with capacity.

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: November 16, 2021
• Study Start: January 15, 2023
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: May 5, 2026

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)