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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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4 May 2013 |
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Main ID: |
CTRI/2009/091/000770 |
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Date of registration:
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12-10-2009 |
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Primary sponsor: |
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Public title:
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A study to know the effects of vitamin B12 on energy expenditure in healthy adult men
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Scientific title:
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Role of vitamin B12 in modulating resting and noradrenaline stimulated energy expenditure in healthy adult men |
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Date of first enrolment:
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01-10-2009 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=944 |
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Study type:
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Interventional |
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Study design:
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Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Sucharita S
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Address:
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Associate Professor Department of Physiology, St John's Medical College
560034
Bangalore, KARNATAKA
India |
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Telephone:
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080 22065060 |
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Email:
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sucharita@sjri.res.in |
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Affiliation:
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Associate Professor |
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Name:
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Dr Sucharita S
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Address:
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Associate Professor Department of Physiology, St John's Medical College
560034
Bangalore, KARNATAKA
India |
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Telephone:
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080 22065060 |
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Email:
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sucharita@sjri.res.in |
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Affiliation:
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Associate Professor |
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Key inclusion & exclusion criteria
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Inclusion criteria: healthy adult men between the age group of 20 to 40 years with serum vitamin b12 levels less than 148 pmol/L
Exclusion criteria: history of chronic diseases like diabetes, hypertension,tuberculosis, malignancy, chronic renal failure, alcohol intake greater than 2STD and any form of anemia and neuropathy
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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human subjects with subclinical Vitamin B12 deficiency based on a serum Vitamin B12 cutoff of <148 pmol/L
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Intervention(s)
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Intervention1: vitamin B12 supplementation: 100 microgram once daily for 4 months
Control Intervention1: nil: nil
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Primary Outcome(s)
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Oxygen consumption, Respiratory quotient, Energy expenditure, Heart rate, Blood pressureTimepoint: at the end of 4 months of Vitamin B12 supplementation
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Secondary Outcome(s)
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Vitamin B12, Homocysteine, Methyl melanoic acid, free fatty acid, Thyriod hormone, Insulin, GlucoseTimepoint: at the end of 4 months of Vitamin B12 supplementation
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Source(s) of Monetary Support
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Research Society, St John's medical College, Bangalore-34
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