GAit, MEmory, Dietary and Vitamin D (GAME-D2)

University Hospital, Angers

Status and phase

Completed

Phase 3

Phase 2

Conditions

Memory Complaint Without Cognitive Decline

Treatments

Dietary Supplement: Yogurt not supplemented with vitamin D and calcium

Dietary Supplement: Yogurt supplemented with vitamin D and calcium

Study type

Interventional

Funder types

Other

Identifiers

NCT02086409

2013-A01499-36

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Female

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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