DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)
NCT ID: NCT01708005
Last Updated: 2012-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
160 participants
INTERVENTIONAL
2012-11-30
2014-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention
80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks
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
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.
Placebo
The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Vitamin D supplementation during inclusion
* Contraindications to vitamin D
* Unstable medical condition
* Enrollment in another simultaneous clinical trial
* Civil defense measures underway
60 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
NUTRISANTE
UNKNOWN
University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Olivier Beauchet, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Angers University Hospital
Locations
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University Hospital
Angers, , France
Countries
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Other Identifiers
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2012-A00453-40
Identifier Type: -
Identifier Source: org_study_id