Impact of different modes of vitamin B12 supplementation on subclinical vitamin B12 deficiency on sensory, motor and cognitive function among older people

Impact of different modes of vitamin B12 supplementation on subclinical vitamin B12 deficiency on sensory, motor and cognitive function among older people: a community based prospective cluster randomised controlled double blind interventional trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN02694183

Enrollment

300

Registered

2009-04-30

Start date

2008-09-01

Completion date

Unknown

Last updated

2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin B12 deficiency Nutritional, Metabolic, Endocrine Deficiency of other B group vitamins

Interventions

A routine fortified food program provided monthly is delivered by the Ministry of Health under the PACAM programme through the health centres. The nutritional products are 1 kg of Años Dorados (a cere

20 subjects per centre/cluster will be included in three arms. Each subject will be included in the study after assessing inclusion and exclusion criteria and will be followed for 18 months. All sub

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women between 70 to 79 years of age 2. Participate in the National Health Service Nutrition Program for Older People (PACAM) targeted to the elderly (70 years or older)

Exclusion criteria

Exclusion criteria: 1. Diabetes (fasting blood glucose greater than or equal to 126 mg/dl) 2. Hypothyroidism (thyroid stimulating hormone [TSH] greater than 6 mlU/l) 3. Serum creatinine greater than or equal to 30 mg/ml 4. Serum vitamin B12 level less than 120 or greater than 700 pmol/l or vitamin B12 supplemented 5. Cerebrovascular disease 6. Previous gastrointestinal surgery 7. Unexplained weight lost greater than or equal to 3 kg in the previous 3 months 8. Low cognitive development (Mini-mental test less than 20, and Pfeffer test greater than 5)

Design outcomes

Primary

Measure	Time frame
1. Serum vitamin B12 status, assessed at initial visit and 3, 9 and 18 months 2. Haematological and biochemical parameters, assessed at initial visit and 3, 9 and 18 months 3. Peripheral nerve conduction, assessed at initial visit, 3 and 18 months 4. Compound muscle action potential (CMAP) amplitude, distal motor latency and F-wave latency (a measure of conduction time from the distal stimulation site to the spinal cord), assessed at initial visit, 3 and 18 months 5. Mini-mental score: Mini Mental State Examination (MMSE), assessed at initial visit and 18 months	—

Measure

Time frame

1. Serum vitamin B12 status, assessed at initial visit and 3, 9 and 18 months 2. Haematological and biochemical parameters, assessed at initial visit and 3, 9 and 18 months 3. Peripheral nerve conduction, assessed at initial visit, 3 and 18 months 4. Compound muscle action potential (CMAP) amplitude, distal motor latency and F-wave latency (a measure of conduction time from the distal stimulation site to the spinal cord), assessed at initial visit, 3 and 18 months 5. Mini-mental score: Mini Mental State Examination (MMSE), assessed at initial visit and 18 months

—

Secondary

Measure	Time frame
1. Serum folate, homocysteine, methyl malonic acid, holo-transcobalamin, assessed at initial visit and 3, 9 and 18 months 2. Neurological battery evaluation include sensory pathways of conduction of afferent sensory pathways of small diameter, quantitative thermal and somatosensory responses, specific neurosensory pathways and visual evoked potential. All techniques will use surface electrodes and limb temperature will be controlled to be above 30°C by suitable heating and blankets. Assessed at initial visit, 3 and 18 months. 3. Cognitive function: Test Wechsler, Consortium to Establish a Registry for Alzheimer's Disease (CERAD), Test Hamilton and Trail Making Test, assessed at initial visit and 18 months	—

Measure

Time frame

1. Serum folate, homocysteine, methyl malonic acid, holo-transcobalamin, assessed at initial visit and 3, 9 and 18 months 2. Neurological battery evaluation include sensory pathways of conduction of afferent sensory pathways of small diameter, quantitative thermal and somatosensory responses, specific neurosensory pathways and visual evoked potential. All techniques will use surface electrodes and limb temperature will be controlled to be above 30°C by suitable heating and blankets. Assessed at initial visit, 3 and 18 months. 3. Cognitive function: Test Wechsler, Consortium to Establish a Registry for Alzheimer's Disease (CERAD), Test Hamilton and Trail Making Test, assessed at initial visit and 18 months

—

Countries

Chile

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026