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
  Purpose

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).


Condition Intervention Phase
Mild Cognitive Impairment
Drug: Lecitone®Se-Vitamin D3
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 160
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks
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
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.

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

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708005

Locations
France
University Hospital
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Nantes University Hospital
NUTRISANTE
Investigators
Principal Investigator: Olivier Beauchet, MD,PhD Angers University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01708005     History of Changes
Other Study ID Numbers: 2012-A00453-40
Study First Received: October 9, 2012
Last Updated: October 15, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés
France: Institutional Ethical Committee

Keywords provided by University Hospital, Angers:
Mild Cognitive Impairment
Vitamin D
Cholecalciferol
Lecitone®Se-Vitamin D3

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 14, 2014