DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change in executive performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention
80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks
Intervention: Lecitone®Se-Vitamin D3 (Drug)
Placebo
80 participants in this arm start the oral intake of placebo the day after inclusion and during 12 weeks.
Then, they start the oral intake of Lecitone®Se-Vitamin D3 12 weeks after inclusion until the 24th week.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in executive performance
Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Executive performance is measured with Trial Making Test part B (TMT B)
Secondary Outcomes
- Change in other executive scores(This outcome is assessed at baseline, 12 and 24 weeks after inclusion.)
- Change in posture(This outcome is assessed at baseline, 12 and 24 weeks after inclusion.)
- Between-group comparison of compliance to treatment(This outcome is assessed at baseline, 12 and 24 weeks after inclusion.)
- Change in gait(This outcome is assessed at baseline, 12 and 24 weeks after inclusion)
- Between-group comparison of tolerance(This outcome is assessed at baseline, 12 and 24 weeks after inclusion)