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ISRCTN
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ISRCTN67437725
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DOI
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10.1186/ISRCTN67437725
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Growth and body composition in undernourished children: effect of vitamin B12 supplementation
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Scientific title
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Growth and body composition in acute severe malnutrition (SAM) in Indian children: effect of vitamin B12 supplementation in a double-blind randomised controlled pilot study
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Acronym
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GROW SAM
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Serial number at source
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0938
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Study hypothesis
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Developing countries like India undergoing rapid industrialisation and transition are facing a dual burden of illness viz. undernutrition and overnutrition. Both of these dimensions of malnutrition contribute to morbidity and mortality in children as well as in adults. It is estimated that undernutrition contributes to 50% of the child deaths in the country. The children who survive nutritional insults during early life are at a high risk of developing non-communicable diseases (NCD) like type 2 diabetes, obesity and cardiovascular disease in later life. India is today a capital of diabetes as well as of undernutrition in under-five children.
The theory of 'developmental origins of health and disease' (DOHaD) suggests that obesity, diabetes and related disorders have origins in nutritional rehabilitation of the undernourished young. Undernutrition followed by overnutrition in later life predisposes to NCD. A major concern in India is to treat and rehabilitate undernourished children especially in the rural population.
We plan to study growth and body composition of undernourished children in the age group of 6 months to 36 months, in Akola district of State of Maharashtra. We plan to study the effect of vitamin B12 supplementation on lean mass deposition during recovery from malnutrition in these children.
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Lay summary
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Ethics approval
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KEM Hospital Research Centre's Ethics Committee approved on the 23rd July 2009 (ref: KEMHRC/VSP/Dir Off/EC/1005)
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Study design
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Double-blind randomised controlled pilot study
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Countries of recruitment
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India
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Disease/condition/study domain
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Acute severe malnutrition (SAM)
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Participants - inclusion criteria
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Children less than or equal to -3 sd weight for height, as per World Health Organization (WHO) growth standards, aged 6 - 36 months
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Participants - exclusion criteria
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Children with acute illness or with incapacitating congenital malformation
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Anticipated start date
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01/07/2010
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Anticipated end date
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30/06/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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Oral supplementation with multiple micronutrients, with and without vitamin B12. 10 g sachets of multiple micronutrients were prepared (as per IOM RDA for 3 year olds); patients were given 1 sachet/day orally (provided in color coded sachets). Total duration of treatment was 6 months.
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Primary outcome measure(s)
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1. Total body water, measured by D2O dilution method, measured at baseline and visit 5
2. Bio-impedance analysis, measured at baseline, visit 3 and visit 5
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Secondary outcome measure(s)
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1. Anthropometry, measured at baseline and visit 5
2. Blood measurements, measured at baseline and visit 5
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Sources of funding
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1. International Atomic Energy Agency (IAEA) (Austria)
2. King Edward Memorial Hospital and Research Centre (India) - Diabetes Unit
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Trial website
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Publications
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Contact name
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Dr
Urmila
Deshmukh
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Address
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Diabetes Unit
KEM Hospital Research Centre
Rasta Peth
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City/town
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Pune
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Zip/Postcode
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411 011
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Country
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India
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Tel
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+91 (0)20 2611 1958
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Fax
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+91 (0)20 2611 1958
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Email
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deshmukh.urmila@gmail.com
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Sponsor
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King Edward Memorial Hospital and Research Centre (India)
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Address
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Diabetes Unit
Rasta Peth
Pune
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City/town
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Maharashtra
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Zip/Postcode
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411011
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Country
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India
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Email
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kemvnr@vsnl.net
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Date applied
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02/09/2010
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Last edited
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15/11/2010
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Date ISRCTN assigned
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15/11/2010
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