DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)

• Status: Unknown status
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Angers
• Collaborators: Nantes University Hospital; NUTRISANTE
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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