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

SLCTR Registration Number

SLCTR/2007/006


Date of Registration

14 Jun 2007

The date of last modification

Jun 07, 2013


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 of Health Condition(s) Studied

Micronutrient status, growth and cognitive function improvement


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

None


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose


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


Primary outcome(s) - Time of assessment(s)

At the end of the study : November 2007


Secondary outcome

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


Secondary outcome(s) - Time of assessment(s)

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



Target number/sample size

200 (100 in each group)


Countries of recruitment

Sri Lanka


Anticipated start date

2007-03-31


Anticipated end date

2007-12-31


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Ruhuna


Funding source

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



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
nmu_galle@yahoo.com

Contact Person for Public Queries









Primary study sponsor/organization

IAEA research grant SRL 11958

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


Officialmail@iaea.org
www.iaea.org

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