Growth and body composition in undernourished children: effect of vitamin B12 supplementation
| ISRCTN | ISRCTN67437725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67437725 |
| Protocol serial number | 0938 |
| Sponsor | King Edward Memorial Hospital and Research Centre (India) |
| Funders | International Atomic Energy Agency (IAEA) (Austria), King Edward Memorial Hospital and Research Centre (India) - Diabetes Unit |
- 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
Scientific
Diabetes Unit
KEM Hospital Research Centre
Rasta Peth
Pune
411 011
India
| Phone | +91 (0)20 2611 1958 |
|---|---|
| deshmukh.urmila@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised controlled pilot study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | GROW SAM |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
1. Total body water, measured by D2O dilution method, measured at baseline and visit 5 |
| Key secondary outcome measure(s) |
1. Anthropometry, measured at baseline and visit 5 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 36 Months |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key exclusion criteria | Children with acute illness or with incapacitating congenital malformation |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- India
Study participating centre
Diabetes Unit
Pune
411 011
India
411 011
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
