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

NCT01708005 | Unknown Phase 2 DMC

• 1 other identifier: 2012-A00453-40
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Vitamin D; Cholecalciferol; Lecitone®Se-Vitamin D3

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Change in other executive scores

  This outcome is assessed at baseline, 12 and 24 weeks after inclusion.

• Change in posture

  This outcome is assessed at baseline, 12 and 24 weeks after inclusion.

• Between-group comparison of compliance to treatment

  This outcome is assessed at baseline, 12 and 24 weeks after inclusion.

• Change in gait

  This outcome is assessed at baseline, 12 and 24 weeks after inclusion

• Between-group comparison of tolerance

  This outcome is assessed at baseline, 12 and 24 weeks after inclusion

Study Arms (2)

Intervention

ACTIVE COMPARATOR

80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks

Drug: Lecitone®Se-Vitamin D3

Placebo

PLACEBO COMPARATOR

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

Interventions

Lecitone®Se-Vitamin D3 DRUG

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.

Intervention

Placebo DRUG

The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications to vitamin D
• Unstable medical condition
• Enrollment in another simultaneous clinical trial
• Civil defense measures underway

Sponsors & Collaborators

• University Hospital, Angers: lead
• Nantes University Hospital: collaborator
• NUTRISANTE: collaborator

Study Sites (1)

University Hospital

Angers, 49933, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Olivier Beauchet, MD,PhD

  Angers University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 16, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 16, 2012

Record last verified: 2012-10

Locations

FR (1)