Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint

NCT02185222 | Completed Phase 3 DMC

• 2 other identifiers: SERC12-TC / D-COG2013-005110-36
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 11

Brief Summary

As recommended allowance of oral vitamine D are unable to ensure the recommended serum concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3 higher than the recommended allowance may slow the cognitive decline of patients with a memory complaint.

Conditions

Memory Disorders; Age-Related Cognitive Decline

Keywords

Vitamin D; Cholecalciferol; 25-hydroxyvitamin D; Memory complaint; Subjective memory complaint; Mild cognitive impairment; Preventive therapy; Cognitive disorders

Outcome Measures

Primary Outcomes (1)

• Changes from baseline memory functions measured by the score of the total recall test from Free and Cued Selective Recall Reminding Test (Rappel Libre / Rappel Indicé 16 items : RL/RI 16) at one year and at two years

  The score of the total recall test from Free and Cued Selective Recall Reminding Test (RL/RI 16) is recommended by a European Task Force consensus.

  Baseline (at inclusion), one year and two years

Secondary Outcomes (19)

• Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years

  Baseline (inclusion), one year and two years

• Evolution of anaemia evaluated by red blood cells count

  Baseline (pre-inclusion), one year and two years

• Evolution of plasma calcium and albumin concentration

  Baseline (pre-inclusion), 45 days, one year and two years

• Evolution of urinary calcium and creatinine concentration

  45 days, one year and two years

• All adverse events

  Up to two years

Study Arms (2)

Cholecalciferol 100 000 UI (Unité Internationale)

EXPERIMENTAL

Oral solution in single-dose : 100 000 UI per month

Drug: Cholecalciferol 100 000 UI

Placebo

PLACEBO COMPARATOR

Oral solution in single-dose per month

Drug: Placebo

Interventions

Cholecalciferol 100 000 UI DRUG

Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years

Also known as: Uvedose

Cholecalciferol 100 000 UI (Unité Internationale)

Placebo DRUG

Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients aged 60 years or older,
• Who report to a memory centre with symptoms of memory complaint,
• Having a Mini-Mental State Examination (MMSE) score strictly \> the 5th percentile for sociocultural level of the patient (GRECO standards for elderly patients),
• Having visual, hearing abilities (authorized equipment) and an oral or written expression sufficient for the suitable realization of the tests,
• Who accept participation in the study and are able to sign the informed consent of the - Affiliated to the French social security system.
• Insufficient 25 OH D serum level : 25 OH D \< 50 nmol/L (20 ng/ml),
• Normal corrected plasma calcium concentration,
• Normal kidney function (cockcroft \> 30 mL/mn)

You may not qualify if:

• Alzheimer's disease or other dementia,
• Parkinson's disease treated,
• Epilepsy treated,
• Huntington's disease,
• Brain tumor,
• History of a progressive disease which may have consequences for the central nervous system (blood pressure, higher or equal to 180/100 mmHg, chronic pulmonary disease with hypoxia; cerebrovascular accident of less than 3 months, cranial traumatism with persistent neurologic deficit, subdural hematoma, brain surgery),
• Antecedent of alcoholism or chronic drug-addiction with an obvious or documented consequence on cognition,
• Severe depression : score Montgomery Asberg Depression Rating Scale (MADRS) \> 18,
• Psychotropic drug therapy (at the discretion of the clinician),
• Hypercalcaemia or treatment for a hypercalcaemia,
• Known hypersensitivity to the vitamin D,
• Granulomatous disease,
• Treatment of vit D at doses higher than the current recommendations,
• History of calcium urinary lithiasis of less than 1 year,
• Nonsteroidal antiinflammatory drug (NSAID) chronic treatment,

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (11)

Chu Angers

Angers, 49933, France

Location

CH BLOIS

Blois, France

Location

CHU BREST - Hôpital de la Cavale Blanche

Brest, 29200, France

Location

CHI ELBEUF Louviers Val-de-Reuil

Elbeuf, France

Location

CHU NANTES - Hôpital Bellier

Nantes, 44093, France

Location

CHU NANTES - Hôpital Laënnec

Nantes, 44093, France

Location

Chr Orleans

Orléans, 45067, France

Location

CHU POITIERS - Hôpital de la Milétrie

Poitiers, 86021, France

Location

CHU RENNES - Hôpital Hôtel Dieu

Rennes, 35064, France

Location

CHU ROUEN - Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHRU TOURS - Hôpital Bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Memory Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fanny HENNEKINE, PH

  CHRU TOURS - Hôpital Bretonneau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 9, 2014
• Study Start: October 23, 2014
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

FR (11)