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Multiple Nutritional Deficiencies Causing Dementia of the Alzheimer Type (ALZ-vit)

This study is not yet open for participant recruitment.
Verified November 2011 by Oslo University Hospital
Sponsor:
Collaborator:
South Eastern Area Health Service
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01479855
First received: September 5, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

The purpose of the study is to compare the concentrations of Vitamin B1 (thiamine), Vitamin B6 (pyridoxal-5-phosphate), folate, Vitamin B12 (cobalamin), Vitamin C (ascorbic acid), Vitamin A (retinol), Vitamin E (alfa-tocopherol), homocystein, uric acid, F2 8-α-isoprostane, 8-deoxyguanosine, retinoids, tau-protein and β-amyloid in spinal fluid, metabolomics, proteomics, m-RNA for DNA repair enzymes and DNA in patients who suffer from mild cognitive impairment (MCI) or mild dementia of Alzheimers type, with healthy controls.

A second aim is to explore the association between vitamin and nutrient reductions, if any, and cognitive function as well as vascular score and possible changes in the MRI.


Condition
Mild Cognitive Impairment
Alzheimers Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multiple Nutritional Deficiencies Causing Dementia of the Alzheimer Type

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Vitamin A [ Time Frame: Up to 4 weeks after inclusion ] [ Designated as safety issue: No ]
    The concentration of Vitamin A = Retinol (1.4-3.4 mmol/l) will be measured in serum from patients and healthy controls, and compared.

  • Vitamin B1 [ Time Frame: Up to 4 weeks after inclusion ] [ Designated as safety issue: No ]
    The concentration of Vitamin B1 = Thiamin diphosphate (55 - 126 nmol/l) will be measured in blood from patients and healthy controls, and compared.

  • Vitamin B6 [ Time Frame: Up to 4 weeks after inclusion ] [ Designated as safety issue: No ]
    The concentration of Vitamin B6 = Pyridoxal-5 phosphate will be measured in serum from patients and healthy controls and compared.

  • Vitamin B12 [ Time Frame: Up to 4 weeks after inclusion ] [ Designated as safety issue: No ]
    The concentration of Vitamin B12 = Cobalamin (140-600 pmol/l) will be measured in serum from patients and healthy controls, and compared.

  • Vitamin C [ Time Frame: Up to 4 weeks after inclusion ] [ Designated as safety issue: No ]
    The consentration of Vitamin C - Ascorbic acid (45-92 mmol/l) will be measured in serum of patients and healthy controls, and compared.

  • Vitamin E [ Time Frame: Up to 4 weeks after inclusion ] [ Designated as safety issue: No ]
    The concentration of Vitamin E = Alfa-tocopherol (16 - 36 mmol/l)will be measured in serum from patients and healthy controls, and compared.


Secondary Outcome Measures:
  • Cognitive function [ Time Frame: The cognitive testing will be performed between 0 to 4 weeks before the blood samples and spinal fluid is collected. ] [ Designated as safety issue: No ]
    The assessment of the cognitive function of patients as well as healthy controls will be done according to a comprehensive test battery used in Memory Clinics in Norway that concists of MMSE-NR, Clock-drawing-test and Ten-Word-Test (CERAD), TMTA and B, Abstract thinking, Boston Naming Test and FAS-COWA.


Biospecimen Retention:   Samples With DNA

Whole blood, serum, urine, cerebrospinal fluid


Estimated Enrollment: 180
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
Patients referred to a memory clinic due to memory problems and their healthy spouse

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients referred consequtively to the Memory Clinic, Oslo University Hospital, Ullevål

Criteria

Inclusion Criteria:

  • Cognitive impairment with a MMSE score of 24 or better.
  • Depression score below 9 both on MADRS and Cornell.

Exclusion Criteria:

  • Acute or chronic disease with CRP above 10.
  • Lewy Body Dementia or Frontal Lobe Dementia.
  • Dementia due to a known brain vascular disturbance, hemorrhage or thrombosis.
  • Patients who had not stopped their intake of vitamins and food additives the last four weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479855

Contacts
Contact: Ingun D Ulstein, MD PhD 95700025 ext +47 ingun.ulstein@aldringoghelse.no
Contact: Thomas Bøhmer, MD PhD t.bohmer@medisin.uio.no

Locations
Norway
OsloUH, Ullevål Not yet recruiting
Oslo, Norway, 0424
Principal Investigator: Ingun D Ulstein, MD PhD            
Sponsors and Collaborators
Oslo University Hospital
South Eastern Area Health Service
Investigators
Principal Investigator: Ingun D Ulstein, MD PhD Oslo University Hospital
  More Information

Publications:

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01479855     History of Changes
Other Study ID Numbers: 2011/698 (REK), Other Identifier
Study First Received: September 5, 2011
Last Updated: November 22, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Mild Cognitive Impairment (MCI)
Alzheimers disease
Vitamines
Nutrients

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Malnutrition
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nutrition Disorders

ClinicalTrials.gov processed this record on June 17, 2013