Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202403614331028 Date of Approval: 28/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving school age nutrition and school performance through amaranth plus flaxseed food product distribution in Sidama, Ethiopia
Official scientific title Improving school age nutrition and school performance through amaranth plus flaxseed food product distribution in Sidama, Ethiopia
Brief summary describing the background and objectives of the trial In Ethiopia, the majority are unable to access adequate amounts of nutrient-rich foods to meet daily dietary requirements. Moreover, primary school age children are vulnerable groups to under-nutrition specifically anaemia and underweight. School feeding programs is one of the strategies to decrease the prevalence of under-nutrition in school children targeting food insecure areas using locally-grown food stuffs. Even if school feeding programs have been initiated in Ethiopia, the majority of vulnerable children have not benefitted from these interventions. Moreover sustainability and inadequate amount of food, and nutrient provision are identified challenges. Exploring underutilized and nutrient rich food sources could be one of the ways to mitigate the shortage of energy and nutrient dense food supplementation for school feeding. Amaranth is one of the few plants where leaves are eaten as a vegetable, while the seeds are used in the same way as cereals. In our previous work, we discovered that amaranth grain which grows as a wild plant has better nutrient content compared with the commonly consumed staple food maize. Also, an amaranth intervention done by this study group in younger children showed a significant effect on decreasing anaemia prevalence in children. But, we did not identify a significant weight or height change in the amaranth group. Further we found that the consumption of fish or seafood in the study area was almost null.This study aims to assess nutritional health and to reduce under-nutrition among school children by preparing amaranth plus flaxseed food in Sidama, Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 20/09/2024
Actual trial start date
Anticipated date of last follow up 20/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 282
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrient and energy dense amaranth plus flaxseed bread Six days/week For 88 days The food will be prepared based on the recommended dietary allowance (RDA); according to RDA the target daily intake of food will be 200g for all children, considered to be an amount that they could comfortably consume in one session. 141
Control Group Commonly used maize food 200g per day five times per week For four months Commonly used maize bread of similar amount and colour as bread given to the intervention group 141 Placebo
Experimental Group Nutrient and energy dense amaranth plus flaxseed bread Six days/week For 88 days The food will be prepared based on the recommended dietary allowance (RDA); according to RDA the target daily intake of food will be 200g for all children, considered to be an amount that they could comfortably consume in one session. 141
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Ascenting children with parents providing informed consent in 1-2 grades learning at selected primary schools will be included. Those who are seriously ill Children with severe malnutrition Children with history of any known allergy or Participating in other trials Child: 6 Year-12 Year 5 Year(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/09/2023 Hawassa University College of Medicine and Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
1560 Hawassa 1560 Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/10/2023 REK
Ethics Committee Address
Street address City Postal code Country
5020 Bergen 7804 Norway
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nutritional anemia (Ferritin, Iron, Hemoglobin, folate, vitamin B-12), at base line and at the end of 4 month
Secondary Outcome Growth (HAZ, BMI/age-change, WAZ) HDL At baseline and the end of four month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shebedino Wereda Primary school Sidama Regional State Leku Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
NORHAD II 1560 Hawassa 1560 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NORHAD 1560 Hawassa 1560 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alemselam Zebdewos Orsango zalemselam@gmail.com +251911000961 1560
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia Hawassa University College of Medicine and Health Science School of Public Health
Role Name Email Phone Street address
Public Enquiries Taye Gari tayegari@gmail.com +251926276598 1560
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia Hawassa University School of Public Health
Role Name Email Phone Street address
Scientific Enquiries Ingunn Marie s. Engebretsen ingunn.engebretsen@uib.no +4797765015 21
City Postal code Country Position/Affiliation
Bergen 5020 Norway Professor Center for International Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The anonymize individual participant data will be shared. Informed Consent Form,Statistical Analysis Plan,Study Protocol with in 12 months after the study completed The principal investigate is the responsible for any question and request for access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 05/02/2025 edition and modification of title Reducing school age under-nutrition through promoting amaranth plus flaxseed food product in Sidama, Ethiopia Improving school age nutrition and school performance through amaranth plus flaxseed food product distribution in Sidama, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 05/02/2025 Edition and modification of title Reducing school age under-nutrition through promoting amaranth plus flaxseed food product in Sidama, Ethiopia Improving school age nutrition and school performance through amaranth plus flaxseed food product distribution in Sidama, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 21/03/2024 date changed due to inconvenience 11 Mar 2024 26 Mar 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 08/07/2024 the anticipated trial start date extended due to logistic supply 26 Mar 2024 20 Sep 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 08/07/2024 Not yet started type error 07 Aug 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 08/07/2024 Because the trial start date is extended 31 Aug 2024 20 Jan 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 08/07/2024 Not yet started 18 Sep 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 05/03/2024 This may be due to my misunderstanding in my case 652 is the sample for survey prior to the trial and then we will be going to recruit total 282 individuals 141 for each group experimental and control group. 652 141
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 14/03/2024 I misunderstand while writing the total number will be 282. 141 for the control group and 141 for the intervention group 141 282
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 05/03/2024 This may be due to my misunderstanding in my case 652 is the sample for survey prior to the trial and then we will be going to recruit total 282 individuals 141 for each group experimental and control group. 282
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 05/03/2024 This may be due to my misunderstanding in my case 652 is the sample for survey prior to the trial and then we will be going to recruit total 282 individuals 141 for each group experimental and control group. 282
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 05/02/2025 we completed recruitment and follow up Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 05/02/2025 feeding frequency is increased to 6 days per week Experimental Group, Nutrient and energy dense amaranth plus flaxseed bread , Five days/week , For four months, The food will be prepared based on the recommended dietary allowance (RDA); according to RDA the target daily intake of food will be 200g for all children, considered to be an amount that they could comfortably consume in one session., 141, Experimental Group, Nutrient and energy dense amaranth plus flaxseed bread , Six days/week , For 88 days , The food will be prepared based on the recommended dietary allowance (RDA); according to RDA the target daily intake of food will be 200g for all children, considered to be an amount that they could comfortably consume in one session., 141,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 05/03/2024 to add more clear version TRUE, Hawassa University College of Medicine and Health Sciences Institutional Review Board , 1560, Hawassa, 1560, Ethiopia, , 09 Sep 2023, +251468209290, zalemselam@yahoo.com, 27277_28274_4737.pdf TRUE, Hawassa University College of Medicine and Health Sciences Institutional Review Board , 1560, Hawassa, 1560, Ethiopia, , 09 Sep 2023, +251468209290, embialle@hu.edu.et, 27277_28274_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/03/2024 "This protocol obtained ethical approval from two additional institutions. The University of Bergen REK granted approval on 11.10.2023 with reference number 656883. They can be reached via email at rek-sorost@medisin.uio.no or by phone at +247-22845502. Furthermore, to adhere to trial regulations in Ethiopia, ethical approval was obtained from Arbaminch University on 04.03.2024 with reference number IRB 23130/2024. They can be contacted via email at irb.amu@yahoo.com. At Hawassa University, direct communication with the chairman of the ethical review board is facilitated through the email address." TRUE, Hawassa University College of Medicine and Health Sciences Institutional Review Board , 1560, Hawassa, 1560, Ethiopia, , 09 Sep 2023, +251468209290, embialle@hu.edu.et, 27277_28274_4737.pdf TRUE, Hawassa University College of Medicine and Health Sciences Institutional Review Board , 1560, Hawassa, 1560, Ethiopia, , 19 Sep 2023, +251468209290, embialle@hu.edu.et, 27277_28274_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/03/2024 PACTR Admin TRUE, Hawassa University College of Medicine and Health Sciences Institutional Review Board , 1560, Hawassa, 1560, Ethiopia, , 19 Sep 2023, +251468209290, embialle@hu.edu.et, 27277_28274_4737.pdf TRUE, Hawassa University College of Medicine and Health Sciences Institutional Review Board , 1560, Hawassa, 1560, Ethiopia, , 19 Sep 2023, +251468209290, rttvp@hu.edu.et, 27277_28274_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 08/07/2024 To upload ethics document TRUE, REK , 5020, Bergen, 7804, Norway, , 11 Oct 2023, +4722845502, rek-sorost@medisin.uio.no, 27277_29727_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 05/03/2024 to revise IPD statment At least for five years after publication of the result with in 12 months after the study completed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 05/02/2025 we changed years because school age starts at 7 years old 5 Year(s) 7 Year(s)