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Completed

NCT Number: NCT02457507

Vitamin B12 Supplement to Prevent Cognitive Decline

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.

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Key information

Conditions

Cognitive Decline Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Chinese University of Hong Kong

Hong Kong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin B12

Dietary Supplement

2 tablets

Placebo

Dietary Supplement

2 tablets

Primary outcomes

  1. Change in Clinical Dementia Rating Scale (CDR)

    Time frame: Change from baseline in CDR at month 9, 18, 27

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 29, 2015
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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