Clinical trial NCT02086409: GAit, MEmory, Dietary and Vitamin D
Official title: Dairy Product, Calcium & Vitamin D Supplementation and Cognitive-motor Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Memory Complaint Without Cognitive Decline
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-03-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in spatiotemporal gait, and in particular in the variability of stride time
timeFrame: This outcome is assessed at baseline and 12 weeks after oral intake.
Secondary outcomes:
measure: Change in posture
timeFrame: This outcome is assessed at baseline and 12 weeks after oral intake.
measure: Change in grip strength
timeFrame: This outcome is assessed at baseline and 12 weeks after oral intake.
measure: Change in executive performance
timeFrame: This outcome is assessed at baseline and 12 weeks after oral intake.
measure: Change in other cognitive scores
timeFrame: These outcomes are assessed at baseline and 12 weeks after oral intake.
measure: Change in the serum concentration of 25 OHD
timeFrame: This outcome is assessed at baseline and 12 weeks after oral intake.
measure: Compliance to intervention
timeFrame: This outcome is assessed 12 weeks after oral intake.
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
state: Maine et Loire
Study officials:
References: