GAit, MEmory, Dietary and Vitamin D

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Memory Complaint Without Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Yogurt supplemented with vitamin D and calcium

20 participants take yogurt supplemented with vitamin D and calcium during 12 weeks

Group Type EXPERIMENTAL

Yogurt supplemented with vitamin D and calcium

Intervention Type DIETARY_SUPPLEMENT

The product is a yogurt containing 200 IU of vitamin D and 400 mg of calcium. Participants take 2 yogurts per day.

Yogurt not supplemented with vitamin D and calcium

20 participants take yogurt not supplemented with vitamin D and calcium during 12 weeks

Group Type ACTIVE_COMPARATOR

Yogurt not supplemented with vitamin D and calcium

Intervention Type DIETARY_SUPPLEMENT

The comparator is represented by a yogurt not supplemented with vitamin D and calcium.Participants take 2 yogurts per day.

Interventions

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Yogurt supplemented with vitamin D and calcium

The product is a yogurt containing 200 IU of vitamin D and 400 mg of calcium. Participants take 2 yogurts per day.

Intervention Type DIETARY_SUPPLEMENT

Yogurt not supplemented with vitamin D and calcium

The comparator is represented by a yogurt not supplemented with vitamin D and calcium.Participants take 2 yogurts per day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes