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

NCT04112732 | Completed

• 1 other identifier: 17016
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aging; Stress

Keywords

Multivitamin; Aging; Stress; Everyday Function; Well-Being

Outcome Measures

Primary Outcomes (1)

• Overall Well-Being (change from baseline)

  An overall outcome measure which is a composite measure made up of four personal well-being questions used in the Measuring National Well-being programme plus one additional question. These five questions are: 1. Overall, how satisfied are you with your life nowadays? 2. Overall, to what extent do you feel the things you do in your life are worthwhile? 3. Overall, how happy did you feel yesterday? 4. Overall, how anxious did you feel yesterday? 5. Overall, how well did you feel yesterday?

  Measured at baseline and then following chronic (12 weeks) treatment

Secondary Outcomes (26)

• Cardiovascular reactivity- Blood pressure (change from baseline)

  Measured at baseline and then following chronic (12 weeks) treatment

• Cardiovascular reactivity- Heart rate (change from baseline)

  Measured at baseline and then following chronic (12 weeks) treatment

• Immune/inflammatory response (change from baseline)

  Measured at baseline and then following chronic (12 weeks) treatment

• Immune/inflammatory response(change from baseline)

  Measured at baseline and then following chronic (12 weeks) treatment

• Self-Reported Stress (change from baseline)

  Measured at baseline and then following chronic (12 weeks) treatment

Study Arms (2)

Multivitamin

EXPERIMENTAL

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

Dietary Supplement: Multivitamin

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Multivitamin DIETARY_SUPPLEMENT

Multivitamin

Multivitamin

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• Vitabiotics: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

Geritol

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: October 2, 2019
• Study Start: November 24, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 29, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)