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

Mild Cognitive Impairment Clinical Trial

— DIET-D  

Official title:

DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01708005
• Other study ID #: 2012-A00453-40
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: October 9, 2012
• Last updated: October 15, 2012
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: October 2012
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertésFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• Lecitone®Se-Vitamin D3
Lecitone®Se-Vitamin D3 is a dietary supplement combining the active ingredients in Lecitone®Se and 100 IU of vitamin D3. This dietary supplement comes in capsule form. Participants take 2 capsules of Lecitone®Se -Vitamin D3 per day. The dose of vitamin D supplementation will not be adjusted except in case of an adverse event such as hypercalcemia. In this case, vitamin D supplementation is stopped and the participant is released prematurely from the study.
• Placebo
The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules.

Locations

Country	Name	City	State
France	University Hospital	Angers

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Nantes University Hospital, NUTRISANTE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in executive performance	Executive performance is measured with Trial Making Test part B (TMT B)	This outcome is assessed at baseline, 12 and 24 weeks after inclusion.	No
Secondary	Change in other executive scores	Test parts A and B, Stoop test, Processing Speed Index	This outcome is assessed at baseline, 12 and 24 weeks after inclusion.	No
Secondary	Change in posture	Time Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking	This outcome is assessed at baseline, 12 and 24 weeks after inclusion.	No
Secondary	Between-group comparison of compliance to treatment	This outcome is assessed together with the serum concentrations of 25OHD and calcium	This outcome is assessed at baseline, 12 and 24 weeks after inclusion.	Yes
Secondary	Change in gait	Time Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking	This outcome is assessed at baseline, 12 and 24 weeks after inclusion	No
Secondary	Between-group comparison of tolerance	This outcome is assessed with the serum concentrations of 25OHD and calcium	This outcome is assessed at baseline, 12 and 24 weeks after inclusion	Yes