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Vitamin B12 Supplement to Prevent Cognitive Decline

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ClinicalTrials.gov Identifier: NCT02457507
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Timothy Kwok, Chinese University of Hong Kong

Brief Summary:

Background: Older diabetic people are at greater risk of cognitive decline than non-diabetic people. Vitamin B12 deficiency in older people is associated with cognitive impairment and Alzheimer's disease. Vitamin B12 deficiency may therefore contribute to cognitive decline in older diabetic people.

Objective: To determine whether the correction of mild vitamin B12 deficiency in cognitively normal older diabetic people reduces the incidence of cognitive decline.

Design: randomized, double blind, placebo controlled trial Subject: Cognitively normal diabetic outpatients aged 70 years or older with plasma vitamin B12 150-300 pmol/L in medical and family medicine/ general outpatient clinics.

Procedure: After excluding those with clinical manifestations of vitamin B12 deficiency and without family member who can reliably inform on cognitive functioning (personal contact at least once a week), eligible patients will be invited to participate in this clinical trial. After obtaining written consent, research assistant (RA) will record demographic and clinical information from the subjects and perform neuropsychological tests - 1. Clinical dementia rating scale (CDR), 2. neurocognitive test battery (see below) 3. Chinese Mini mental state examination (MMSE), 4. Geriatric depression scale (GDS). Fasting blood will be taken for serum methylmalonic acid (MMA). Those with cognitive impairment and significant comorbidities will be excluded.

264 eligible subjects will be randomly assigned to take either two Vitamin B12 500 microgram or two identical looking placebo tablets once daily for 27 months.

All subjects or family caregivers are reviewed in the research clinic every 12 weeks in which the research assistant performs a pill count and dispenses the trial tablets. At 9 monthly intervals, the subjects will have neurocognitive test battery repeated at research clinic. CDR will be repeated at month 18 and 27. At month 9 and 27, fasting serum MMA and vitamin B12 will be repeated.


Condition or disease Intervention/treatment Phase
Cognitive Decline Dietary Supplement: Vitamin B12 Dietary Supplement: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : August 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arm Intervention/treatment
Experimental: Vitamin B12
Vitamin B12, 1mg, daily, 27 months
Dietary Supplement: Vitamin B12
2 tablets

Placebo Comparator: Placebo
Placebo comparator
Dietary Supplement: Placebo
2 tablets




Primary Outcome Measures :
  1. Change in Clinical Dementia Rating Scale (CDR) [ Time Frame: Change from baseline in CDR at month 9, 18, 27 ]

Secondary Outcome Measures :
  1. Change in Neurocognitive test battery (NTB) score [ Time Frame: Change from baseline in NTB score at month 9, 18, 27 ]
    NTB including tests of executive funciton, psychomotor speed and memory

  2. Change in serum homocysteine (µmol/L) [ Time Frame: Change from baseline in serum homocysteine at month 9, 27 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • >/= 70 years old
  • B12: 150 - 300 pmol/L
  • Caregiver (personal contact at least once a week)

Exclusion Criteria:

  • Dementia
  • Peripheral neuropathy
  • Anaemia (Hb<10 g/dl)
  • Renal failure (creatinine > 150 µmol/L
  • Stroke

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457507


Locations
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China
The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Timothy Kwok, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02457507     History of Changes
Other Study ID Numbers: DM-B12
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Vitamins
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics