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


Funded By: Co-ordinated Research Project: Management of Severe Acute Malnutrition during Early Life; Addressing Nutritional Requirements by Stable Isotope Techniques. E43022. International Atomic Energy Agency, Viennna, Austria.
Month & Year of Commencement:  2009
Current Status:  Ongoing

Principal Investigator:  Dr. U.S. Deshmukh, Research Assistant, KEM Hospital and Research Centre,Pune,India
Co-Investigator:  Dr.C.S.Yajnik,Director,Diabetes Unit, KEM Hospital and Research Centre,Pune,India




GROSAM1        GROSAM2

» Background
» Objective
» Methodology and Design
» Current status


Background

Developing countries like India undergoing rapid industrialization 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.

In the Pune Maternal Nutrition Study we have shown that maternal imbalance in one-carbon metabolism (low vitamin B12 and high folate status) was associated with adiposity and insulin resistance in the offspring at 6 years. We hypothesized that vitamin B12 supplementation to undernourished children will enhance lean mass accrual during recovery.

Objective

Our objective was to study body composition in children suffering from severe acute malnutrition (SAM, weight for heightless than -3sd) in rural community, and to study effect of oral, six months of vitamin B12 supplementation on body composition in a community-based, randomised trial.

Methodology and Design

Study site: Akola district of Maharashtra, India. Data collection: The study children would be supplemented with multiple micronutrients with or without 2 mcg vitamin B12 for a period of 6 months. They will be followed up every 6 weeks for anthropometry, morbidity, dietary intake etc. Body composition will be studied by anthropometry, bioimpedance and deuterium dilution technique. The project has been registered at controlled trial registry (ISRCTN67437725).

Current status

Due to the introduction of a new government policy for community-based management of SAM children in the state, the ongoing project was presented to the Ethics Committee for ethical reconsideration. New recruitment of children was withheld, interim data have been collected and being analysed with due permission from KEM Hospital Research Centre’s IRB. The data was presented to the Data Safety Monitoring Board (DSMB).

The DSMB submitted its report on 2nd July 2011. The DSMB’s decision was presented to the Ethics Committee on 30th July 2011. As per the DSMB decision the study cannot be continued with the same protocol. The plan is to submit a new protocol with the objective to continue investigating body composition (using anthropometry, bioimpedance analysis and D2O dilution technique) of the children, without supplementation protocol, and follow the new government policy of community-based SAM management.

Follow-up measurements of the children, to study growth and body composition changes over 18 months is now completed. Laboratory and data analysis would be completed by September 2012 and the results will be presented at the International Malnutrition Task Force meeting at Ghana in December 2012.


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