Usefulness of ‘Thriposha’ in improving growth and micronutrient status

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2007/006
• Date of registration: 14/06/2007
• Primary sponsor: IAEA research grant SRL 11958
• Public title: Usefulness of ‘Thriposha’ in improving growth and micronutrient status
• Scientific title: Nutrition intervention in Sri Lanka; assess the efficacy and interactions of micronutrients in the thriposha supplement
• Date of first enrolment: 31/3/2007
• Target sample size: 100 children per group
• Recruitment status: Completed
• URL: http://www.slctr.lk/trial_details.asp?reg_id={827C43AE-13B4-480F-B094-256149CFBDD4}
• Study type: Interventional
• Study design: Healthy children aged between 3 and 5 years (an equal proportion of male and female) who have no infectious diseases, respiratory tract infections or diarrheal illnesses within the preceding two weeks will be selected from the university field training area of the Faculty of Medicine, Galle. All subjects will be assessed for the baseline score of their cognitive status by the psychologist in the team using leiter international performance scale. Two weeks prior to the start of the study and at the end of intervention, approximately 3 ml of blood will be drawn for the baseline assessment of haemoglobin, serum concentrations of ferritin, zinc, folate, calcium, vitamin A and vitamin D. Further, a urine sample (50 mL) will be taken to measure the urinary iodide level. Their cognitive functions will be re-assessed at the end of intervention

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. Manjula Hettiarachchi
• Affiliation: Lecturer in Nuclear Medicine

• Name: Dr. Manjula Hettiarachchi
• Affiliation: Lecturer in Nuclear Medicine

Key inclusion & exclusion criteria

Inclusion criteria: Healthy children aged between 3 and 5 years
Exclusion criteria: Having an infectious diseases, respiratory tract infections or diarrheal illnesses within the preceding two weeks or consuming any micronutrient supplement

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Micronutrient status, growth and cognitive function improvement

Intervention(s)

The study sample (total of 250 children) will be grouped into two (interventional and control) after matching according to their initial age, anthropometry and haemoglobin concentrations. Then they will be given Thriposha (either the usual formulae for intervention group) or without mineral and vitamin premix for control group for a period of nine months. Thriposha will be given to each child to be consumed daily (50 gms) preferably two hours after the breakfast or lunch. After nine months of intervention, children will be subjected to re-assessment for anthropometry, blood, serum and urinary parameters

Primary Outcome(s)

Improvement if any in anthropometry, micronutrient status and cognitive status of subjects

Secondary Outcome(s)

-Improving the general nutritional status of children
-Improving the composition of micronutrients if any antagonistic or synergistic interactions between them are found

Secondary ID(s)

IAEA-SRL-11958, research grant sponsor - International atomic energy agency

Source(s) of Monetary Support

International Atomic Energy Agency (IAEA) and Nutrition Coordination Division of the Ministry of Health, Nutrition and welfare

Secondary Sponsor(s)

Dr (Mrs). S.R.H.P. Gunawardena