Improving Everyday Functioning in Adults Aged 70 and Over Using a Multivitamin Supplement

NCT ID: NCT04112732

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-24
• Study Completion Date: 2021-09-30

Brief Summary

Investigation of the chronic effect of 12 week multivitamin supplementation on markers of everyday function in adults aged 70 and over.

Detailed Description

Everyday functioning relates to how well an individual can function independently in day-to-day life. As a person ages, there are various changes which occur in the body, which can lead to a decline in everyday functioning. There is a loss of bone density, the immune system naturally declines which can lead to a susceptibility to autoimmune diseases, infection and cardiovascular disease. Many older adults report feeling socially isolated and lonely, which can also lead to poor mood and negative health outcomes. Due to advancements in society, there has been an increase in older adult informal caregivers, which is a form of chronic stress associated with a range of negative outcomes and declines in functioning.

Nutritional supplementation may have the potential to improve everyday functioning in older adults, which may have declined through ageing alone or ageing alongside chronic stress from being a caregiver. Research had shown multivitamin supplementation to have positive cognitive, mood, mobility and health effects. As well as improving general day-to-day well-being and functioning, and may have the ability to reduce feeling of stress.

The current study will investigate the effects of a multivitamin supplement following daily intake for 12 weeks on a range of everyday functioning outcomes in adults aged 70 and over. The outcome measures include; well being, cardiovascular reactivity, immune response, stress, self-reported health, daily functioning behaviours, mobility, mood, cognitive function, sleep quality and loneliness.

Amendment to protocol:

The recent Covid-19 restrictions have led to changes to the original protocol. Specifically, a group of participants who completed their baseline assessment as per the outlined protocol could not complete the final testing visit as initially planned because of the imposed lockdown For these participants, all follow-up questionnaire-based assessments have been conducted online from their home.

These necessary changes to the method of data collection will be a confounding factor in this group, which would not be comparable to the main dataset. Therefore, the decision has been made to un-blind the researcher to this group of participants' treatment (11 who completed in full prior and 34 who completed testing visit 2 online).

This will allow the main outcome measures to be compared in this unique group of participants', as well as comparisons between outcome measures in those who completed pre and during lockdown.

Conditions

Aging; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Multivitamin

1 multivitamin tablet administered by mouth daily for 12 weeks, to be taken with main meal.

Group Type: EXPERIMENTAL

Multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Multivitamin

Placebo

1 placebo tablet administered by mouth daily for 12 weeks, to be taken with main meal.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Multivitamin

Multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged over 70
• Both caregivers and non caregivers will be recrtuied

Exclusion Criteria

• Allergy to soya
• Participants must not be currently taking the investigational product (or another equivalent multivitamin); any participants who report multivitamin use must be willing to have a washout for 4 weeks before participating (if not willing to do this they will be excluded)
• If a participant has epilepsy, a thyroid disorder, haemochromatosis or suffers from food allergies they must consult their doctor/pharmacist before taking part

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vitabiotics

UNKNOWN

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northumbria University

Newcastle upon Tyne, , United Kingdom

Countries

United Kingdom

Other Identifiers

17016

Identifier Type: -

Identifier Source: org_study_id