Clinical trial NCT01708005: DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)
Official title: DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Vitamin D
Cholecalciferol
Lecitone®Se-Vitamin D3
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Nantes University Hospital
name: NUTRISANTE
First posted: 2012-10-16
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effect after 12 weeks of the oral intake of Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive performance in Trial Making Test score part B (this test evaluate executive functions of mental flexibility) in older adults with Mild Cognitive Impairment (MCI).

Detailed description: Current treatments for Alzheimer's disease (AD) are symptomatic and can only temporarily slow down AD without altering its natural evolution. The development of new therapies has primarily focused on preventing the progression of AD. This therapeutic strategy involves being interested in patients with an early stage of AD such as a mild cognitive impairment (MCI). We hypothesized that the combination of Lecitone®Se with 200 IU/day of vitamin D can slow or even improve cognitive decline, particularly executive functions.

The primary objective of this trial is to compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in performance obtained in the TMT B in the older adults with a MCI.

The secondary objectives of the study are as follows:

* To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in executive performance in patients with a MCI.
* To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in variability of stride time in patients with a MCI.
* To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in executive performance in patients with a MCI.
* To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in variability of stride time in patients with a MCI.
* To determine the compliance and tolerance of the oral intake of Lecitone®Se-Vitamin D3 in patients with a MCI.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years
* Memory complaints
* No dementia (DSM-IV, NINCDS-ADRDA negative)
* No depression (Geriatric Depression score ≤ 5/15)
* Ability to walk a distance of 15 meters unaided
* Diagnosis of MCI
* 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)
* To have given and signed an informed consent to participate in the trial
* To be affiliated to French Social Security

Exclusion Criteria:

* Others cognitive disorders (untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke, severe depressive symptomatology (Geriatric Depression score \> 5/15), existence of dementia according to DSM-IV and NINCDS-ADRDA criteria at the time of inclusion)
* Vitamin D supplementation during inclusion
* Contraindications to vitamin D
* Unstable medical condition
* Enrollment in another simultaneous clinical trial
* Civil defense measures underway

Primary outcomes:
measure: Change in executive performance
timeFrame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Secondary outcomes:
measure: Change in other executive scores
timeFrame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
measure: Change in posture
timeFrame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
measure: Between-group comparison of compliance to treatment
timeFrame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
measure: Change in gait
timeFrame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
measure: Between-group comparison of tolerance
timeFrame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: Angers University Hospital
name: Olivier Beauchet, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: