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SLCTR Registration Number
SLCTR/2007/006
Date of Registration
The date of last modification
Aug 05, 2012
View original TRDS
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 âThriposhaâ in improving growth and micronutrient status
Disease or Health Condition(s) Studied
Micronutrient status, growth and cognitive function improvement
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
IAEA-SRL-11958, research grant sponsor - International Atomic Energy Agency
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
Study Phase
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)
|
1.
Improvement if any in anthropometry, micronutrient status and cognitive status of subjects |
[ At the end of the study : November 2007 ] |
Secondary outcome(s)
|
1.
-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
2007-03-31
Anticipated end date
2007-12-31
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
International Atomic Energy Agency (IAEA) and Nutrition Coordination Division of the Ministry of Health, Nutrition and Welfare
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
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
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
