Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01708005
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01708005
Study Brief:
Protocol Section:
NCT01708005