Home » Trials » SLCTR/2007/006

Nutrition intervention in Sri Lanka; assess the efficacy and interactions of micronutrients in the thriposha supplement


SLCTR Registration Number


Date of Registration

14 Jun 2007

The date of last modification

Mar 03, 2019

View original TRDS

Trial Status

Application Summary

Scientific Title of Trial

Nutrition intervention in Sri Lanka; assess the efficacy and interactions of micronutrients in the thriposha supplement

Public Title of Trial

Usefulness of ‘Thriposha’ in improving growth and micronutrient status

Disease or Health Condition(s) Studied

Micronutrient status, growth and cognitive function improvement

Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

IAEA-SRL-11958, research grant sponsor - International Atomic Energy Agency

Trial Details

What is the research question being addressed?

How efficacious Thriposha is in improving the growth and micronutrient (iron, zinc, calcium and iodine) vit A and vit D status in children? Are there any existing antagonistic or synergistic interactions between micronutrients (iron, zinc, calcium and iodine) vit A and vit D in Thriposha? Does supplementation of thriposha improves the cognitive functions in children? By a controlled efficacy study

Type of study


Study design


Randomized controlled trial


Masking not used


Standard therapy/practice




Supportive care

Study Phase

Not Available

Intervention(s) planned

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.
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

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

Primary outcome(s)


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


At the end of the study : November 2007


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


Throughout the research programme i.e., April 2007 to November 2007


Target number/sample size

200 (100 in each group)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status

Complete: follow up complete

Funding source

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

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number

Not available

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Ruhuna
Institutional Address:PO Box 70, Labuduwa Rd, Galle, Sri Lanka
Telephone:+94-91-2234801/803 (Extension: 161)
Email: ethics@med.ruh.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. Manjula Hettiarachchi
Lecturer in Nuclear Medicine
Nuclear Medicine Unit, Faculty of Medicine, University of Ruhuna, Galle
+94 91 2234801

+94 91 2222314

Contact Person for Public Queries

Primary study sponsor/organization

IAEA research grant SRL 11958

Nutrition and Health Related Environmental Studies Division IAEA, Vienna, Austria


Secondary study sponsor (If any)

Dr (Mrs). S.R.H.P. Gunawardena
Acting Director
Nutrition Co-ordination Division, 7th floor, Anti Malaria Campaign Building, 555/5, Colombo
+91 11 2368323
+91 11 2368320

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not Available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results