Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/09/2010
Date assigned
15/11/2010
Last edited
15/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes