Growth and body composition in undernourished children: effect of vitamin B12 supplementation

ISRCTN ISRCTN67437725
DOI https://doi.org/10.1186/ISRCTN67437725
Secondary identifying numbers 0938
Submission date
02/09/2010
Registration date
15/11/2010
Last edited
15/11/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Urmila Deshmukh
Scientific

Diabetes Unit
KEM Hospital Research Centre
Rasta Peth
Pune
411 011
India

Phone +91 (0)20 2611 1958
Email deshmukh.urmila@gmail.com

Study information

Study designDouble-blind randomised controlled pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleGrowth and body composition in acute severe malnutrition (SAM) in Indian children: effect of vitamin B12 supplementation in a double-blind randomised controlled pilot study
Study acronymGROW SAM
Study objectivesDeveloping 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(s)KEM Hospital Research Centre's Ethics Committee approved on the 23rd July 2009 (ref: KEMHRC/VSP/Dir Off/EC/1005)
Health condition(s) or problem(s) studiedAcute severe malnutrition (SAM)
InterventionOral 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 typeSupplement
Primary outcome measure1. 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 measures1. Anthropometry, measured at baseline and visit 5
2. Blood measurements, measured at baseline and visit 5
Overall study start date01/07/2010
Completion date30/06/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit36 Months
SexBoth
Target number of participants100
Key inclusion criteriaChildren less than or equal to -3 sd weight for height, as per World Health Organization (WHO) growth standards, aged 6 - 36 months
Key exclusion criteriaChildren with acute illness or with incapacitating congenital malformation
Date of first enrolment01/07/2010
Date of final enrolment30/06/2011

Locations

Countries of recruitment

  • India

Study participating centre

Diabetes Unit
Pune
411 011
India

Sponsor information

King Edward Memorial Hospital and Research Centre (India)
Hospital/treatment centre

Diabetes Unit
Rasta Peth
Pune
Maharashtra
411011
India

Email kemvnr@vsnl.net
ROR logo "ROR" https://ror.org/056yyyw24

Funders

Funder type

Research organisation

International Atomic Energy Agency (IAEA) (Austria)
Private sector organisation / International organizations
Alternative name(s)
IAEA
Location
Austria
King Edward Memorial Hospital and Research Centre (India) - Diabetes Unit

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan