Contact information
Type
Scientific
Primary contact
Dr Urmila Deshmukh
ORCID ID
Contact details
Diabetes Unit
KEM Hospital Research Centre
Rasta Peth
Pune
411 011
India
+91 (0)20 2611 1958
deshmukh.urmila@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0938
Study information
Scientific title
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
Acronym
GROW SAM
Study hypothesis
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.
Ethics approval
KEM Hospital Research Centre's Ethics Committee approved on the 23rd July 2009 (ref: KEMHRC/VSP/Dir Off/EC/1005)
Study design
Double-blind randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute severe malnutrition (SAM)
Intervention
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.
Intervention type
Supplement
Phase
Not Applicable
Drug names
B12 supplementation
Primary outcome measures
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
Secondary outcome measures
1. Anthropometry, measured at baseline and visit 5
2. Blood measurements, measured at baseline and visit 5
Overall trial start date
01/07/2010
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Children less than or equal to -3 sd weight for height, as per World Health Organization (WHO) growth standards, aged 6 - 36 months
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant exclusion criteria
Children with acute illness or with incapacitating congenital malformation
Recruitment start date
01/07/2010
Recruitment end date
30/06/2011
Locations
Countries of recruitment
India
Trial participating centre
Diabetes Unit
Pune
411 011
India
Sponsor information
Organisation
King Edward Memorial Hospital and Research Centre (India)
Sponsor details
Diabetes Unit
Rasta Peth
Pune
Maharashtra
411011
India
kemvnr@vsnl.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
International Atomic Energy Agency (IAEA) (Austria)
Alternative name(s)
IAEA
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Austria
Funder name
King Edward Memorial Hospital and Research Centre (India) - Diabetes Unit
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary