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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

Tracking Information
First Submitted Date  ICMJE May 22, 2015
First Posted Date  ICMJE May 29, 2015
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE August 2011
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
Change in Clinical Dementia Rating Scale (CDR) [ Time Frame: Change from baseline in CDR at month 9, 18, 27 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02457507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
  • 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
  • Change in serum homocysteine (µmol/L) [ Time Frame: Change from baseline in serum homocysteine at month 9, 27 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin B12 Supplement to Prevent Cognitive Decline
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Cognitive Decline
Intervention  ICMJE
  • Dietary Supplement: Vitamin B12
    2 tablets
  • Dietary Supplement: Placebo
    2 tablets
Study Arms  ICMJE
  • Experimental: Vitamin B12
    Vitamin B12, 1mg, daily, 27 months
    Intervention: Dietary Supplement: Vitamin B12
  • Placebo Comparator: Placebo
    Placebo comparator
    Intervention: Dietary Supplement: Placebo
Publications * Kwok T, Lee J, Ma RC, Wong SY, Kung K, Lam A, Ho CS, Lee V, Harrison J, Lam L. A randomized placebo controlled trial of vitamin B(12) supplementation to prevent cognitive decline in older diabetic people with borderline low serum vitamin B(12). Clin Nutr. 2017 Dec;36(6):1509-1515. doi: 10.1016/j.clnu.2016.10.018. Epub 2016 Oct 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2015)
271
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 100 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02457507
Other Study ID Numbers  ICMJE DM-B12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy Kwok, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese University of Hong Kong
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP