Home » Trials » SLCTR/2026/027
Impact assessment: Provision of Fortified Rice to School children aged 8 - 9 years in Sri Lanka
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SLCTR Registration Number
SLCTR/2026/027
Date of Registration
The date of last modification
Oct 06, 2026
Scientific Title of Trial
Impact assessment: Provision of Fortified Rice to School children aged 8 - 9 years in Sri Lanka
Public Title of Trial
The effect of fortified rice on iron status and anthropometric outcomes compared to non-fortified rice in schoolchildren aged 8–9 years in Sri Lanka: a randomized controlled trial.
Disease or Health Condition(s) Studied
Iron deficiency anaemia
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1338-9568
Any other number(s) assigned to the trial and issuing authority
MRI-ERC approval No. 26/2024
What is the research question being addressed?
Does provision of fortified rice through the school meal programme improve iron status and anthropometric outcomes among schoolchildren aged 8–9 years in Sri Lanka compared with non-fortified rice?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Outcome assessors
Control
Active
Assignment
Parallel
Purpose
Screening
Study Phase
Not Applicable
Intervention(s) planned
Setting and allocation: This is a two-arm, parallel, cluster randomised trial in Type 2 and Type 3 government schools in Hambantota District, Sri Lanka. Schools will be allocated 1:1 to the intervention or control arm using stratified block randomisation. One classroom will be selected from each school, with 15 children enrolled per classroom. The planned sample is 12 schools and 180 children per arm. Masking will not be used.
Intervention arm — fortified rice: Each participating child will receive 75 g of cooked rice on every school day through the school meal programme for six months. The rice will be prepared from raw rice fortified with 7 mg elemental iron (as micronised ferric pyrophosphate) and 65 µg folic acid per 100 g of raw rice.
Control arm — non-fortified rice: Each participating child will receive 75 g of cooked, non-fortified rice on every school day through the same school meal programme for six months. This is an active comparator, as children in both arms receive a school meal; the comparison concerns rice fortification.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change in haemoglobin level: Haemoglobin concentration measured from venous blood using a three-part haematology analyser (Full Blood Count with Hb) |
[ Baseline, 3 months, and 6 months ] |
|
2.
Change in serum ferritin level Serum ferritin concentration measured from venous blood using a fully automated immunoassay analyser |
[ Baseline, 3 months, and 6 months ] |
Secondary outcome(s)
|
1.
Change in prevalence of anaemia: Proportion of participants meeting anaemia criteria based on haemoglobin assessment |
[ Baseline, 3 months, and 6 months ] |
|
2.
Change in prevalence of iron deficiency: proportion of participants meeting iron deficiency criteria based on serum ferritin with CRP correction |
[ Baseline, 3 months, and 6 months ] |
|
3.
Change in prevalence of iron deficiency anaemia: Iron deficiency anaemia defined as presence of both anaemia and iron deficiency; ferritin <12 µg/L if CRP <6 mg/L or ferritin <15 µg/L if CRP >5 mg/L |
[ Baseline, 3 months, and 6 months ] |
|
4.
Change in height: Height measured using a stadiometer |
[ Baseline, 3 months, and 6 months ] |
|
5.
Change in weight: Weight measured using a Seca weighing scale |
[ Baseline, 3 months, and 6 months ] |
|
6.
Change in mid-upper arm circumference (MUAC): MUAC measured using a non-stretchable MUAC tape |
[ Baseline, 3 months, and 6 months ] |
Target number/sample size
360 participants total (180 per arm, 12 clusters (classrooms) per arm, 15 children per classroom
Countries of recruitment
Sri Lanka
Anticipated start date
2026-10-08
Anticipated end date
2027-10-08
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Gates foundation
Regulatory approvals
Ministry of Health
Status
Approved
Date of Approval
2024-12-20
Approval number
26/2024
Details of Ethics Review Committee
| Name: | Medical Research Institute - Ethics Review Committee |
| Institutional Address: | Medical Research Institute Colombo 8 |
| Telephone: | 0112 693 532 |
| Email: | ethics.mri@gmail.com |
Primary study sponsor/organization
Medical Research Institute
Director, MRI
PO Box 527, Dr. Danister De Silva Mawatha, Colombo 8, Western, Colombo, 00800, Sri Lanka
0112 693 532
director@mri.gov.lk
Secondary study sponsor (If any)
Gates Foundation
Lead - Nutrition
P. O. Box 23350
Seattle, Washington 98102
USA
ruchika.chughsachdeva@gatesfoundation.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
