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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Nantes University Hospital
NUTRISANTE
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01708005
First received: October 9, 2012
Last updated: October 15, 2012
Last verified: October 2012

October 9, 2012
October 15, 2012
November 2012
November 2014   (final data collection date for primary outcome measure)
Change in executive performance [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion. ] [ Designated as safety issue: No ]
Executive performance is measured with Trial Making Test part B (TMT B)
Same as current
Complete list of historical versions of study NCT01708005 on ClinicalTrials.gov Archive Site
  • Change in other executive scores [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion. ] [ Designated as safety issue: No ]
    Test parts A and B, Stoop test, Processing Speed Index
  • Change in posture [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion. ] [ Designated as safety issue: No ]
    Time Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
  • Between-group comparison of compliance to treatment [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion. ] [ Designated as safety issue: Yes ]
    This outcome is assessed together with the serum concentrations of 25OHD and calcium
  • Change in gait [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion ] [ Designated as safety issue: No ]
    Time Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
  • Between-group comparison of tolerance [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion ] [ Designated as safety issue: Yes ]
    This outcome is assessed with the serum concentrations of 25OHD and calcium
Same as current
Not Provided
Not Provided
 
DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)
DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial

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).

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Mild Cognitive Impairment
  • 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.

    Other Name: Lecitone®Se-Vitamin D3
  • Drug: Placebo
    The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules.
    Other Name: Placebo
  • Active Comparator: Intervention
    80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks
    Intervention: Drug: Lecitone®Se-Vitamin D3
  • Placebo Comparator: 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: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
160
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01708005
2012-A00453-40
Yes
University Hospital, Angers
University Hospital, Angers
  • Nantes University Hospital
  • NUTRISANTE
Principal Investigator: Olivier Beauchet, MD,PhD Angers University Hospital
University Hospital, Angers
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP