GAit, MEmory, Dietary and Vitamin D

Phase 2

Completed

• Conditions: Memory Complaint Without Cognitive Decline
• Interventions: Dietary Supplement: Yogurt not supplemented with vitamin D and calcium; Dietary Supplement: Yogurt supplemented with vitamin D and calcium

• Registration Number: NCT02086409
• Lead Sponsor: University Hospital, Angers

Brief Summary

Gait and posture disorders are very common in subjects aged 65 and over, and result mainly from neuromuscular and cognitive disorders.

Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the intake of vitamin D combined or not with calcium may improve muscle strength and cognitive performance.

The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and executive performance, 2) and that this improvement depends of the initial level of vitamin D deficiency.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Study Start: 2014-09
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Woman aged 65 and over
• To have hypovitaminosis D (i.e. serum 25-hydroxyvitamin D [25OHD] concentration ≤ 30ng/mL)
• To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65mmol/L)
• Ability to walk a distance of 15 meters unaided
• Ability to eat 2 yogurts per day
• Memory complaint without cognitive decline
• To have given and signed an informed consent to participate in the trial
• To be affiliated to French Social Security
• To have no vitamin D supplementation during inclusion

Exclusion Criteria

• Existence of dementia according to DSM-IV and NINCDS-ADRDA criteria and others cognitive disorders: untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke with sequelae, depressive symptomatology (Geriatric Depression Scale > 5/15)
• Osteoarticular diseases of the lower members and / or spine altering the biomechanical characteristics of the body.
• Vitamin D supplementation during inclusion
• Contraindications to vitamin D
• Unstable medical condition
• Dairy allergy
• Taste of dairy products not supported
• Enrolment in another simultaneous clinical trial
• Civil defense measures underway
• Refusal to participate of the subject

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yogurt not supplemented with vitamin D and calcium	Yogurt not supplemented with vitamin D and calcium	20 participants take yogurt not supplemented with vitamin D and calcium during 12 weeks
Yogurt supplemented with vitamin D and calcium	Yogurt supplemented with vitamin D and calcium	20 participants take yogurt supplemented with vitamin D and calcium during 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in spatiotemporal gait, and in particular in the variability of stride time	This outcome is assessed at baseline and 12 weeks after oral intake.	Stride time variability is measured with spatiotemporal analysis of walking

Secondary Outcome Measures

Name	Time	Method
Change in posture	This outcome is assessed at baseline and 12 weeks after oral intake.	Posture is evaluated with Time Up \& Go, Five Time Sit-to-Stand and posture analysis with a platform.
Change in other cognitive scores	These outcomes are assessed at baseline and 12 weeks after oral intake.	Executive scores are assessed with digit span test (forward and backward), Trial Making Test part A (TMT A), Stoop test and Processing Speed Index
Change in grip strength	This outcome is assessed at baseline and 12 weeks after oral intake.	Grip strength is measured with a dynamometer.
Change in executive performance	This outcome is assessed at baseline and 12 weeks after oral intake.	Executive performance is measured with Trial Making Test part B (TMT B)
Change in the serum concentration of 25 OHD	This outcome is assessed at baseline and 12 weeks after oral intake.	This outcome is assessed with the serum concentrations of 25OHD
Compliance to intervention	This outcome is assessed 12 weeks after oral intake.	Compliance is measured by the number of yogurt capsules returned

Trial Locations

Locations (1)

Centre Hospitalier Universitaire d'Angers; 🇫🇷 Angers, Maine et Loire, France