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.: PACTR201705002283263 Date of Approval: 11/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Anemia prevention
Official scientific title Preventing iron deficiency anemia: Evaluation of amaranth grain supplementation to 24.0-59.9 month old children in southern Ethiopia, a randomized controlled trial
Brief summary describing the background and objectives of the trial Introduction: Malnutrition is a public health problem in Ethiopia. Different studies show that amaranth grain has better levels of macro and micronutrients especially iron to address the widespread malnutrition problem than other frequently used crops. This useful plant is widely grown in the research area, but it considered as a weed rather than a food crop by the community. Furthermore, adequate research has not been conducted in Ethiopia on amaranth¿s potential to contribute in reducing the malnutrition problem. The research will inform the public at large, policy makers and the academicians as it deals with an underutilized nutritious crop that has the potential to contribute to reduce the malnutrition problem in the country. Objective: To assess the iron deficiency status of children and to evaluate the effect of an amaranth containing bread consumption on the anthropometry and iron deficiency status of children in the age of 24.0-59.9 months. Methodology: In the randomized controlled trial, 100 children with hemoglobin level of less than 11 mg /dl and above 7 mg/dl (mild and moderate anemia) will be recruited into the trial after informed consent. Severely ill individuals will be referred to Hawassa Referal Hospital. Kebele-stratified simple random sampling will ensure 1:1 allocation to each group. The study subjects and parents (other caregivers in the absence of parents) will be kept uniformed about the trial allocation. Statistical analysis will be done using the latest SPSS version and ENA for SMART software. Conclusion: This research project has the potential to be hypothesis generating and will inform policy makers and scientists about amaranth¿s potential to combat malnutrition specifically iron deficiency in the area.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anemia,Circulatory System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/04/2017
Actual trial start date 14/04/2017
Anticipated date of last follow up 14/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Closed to recruitment,follow-up continuing
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Numbered containers 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 Amaranth 150gm 6month 150gm bread containing 70% of amaranth grain 50
Control Group Maize group 150g maize bread 6month control group eat 100% maize containing bread every day for 6 month 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children 24 months up to 59 months Children with hemoglobin level 7 to <11 mg/dl Currently residing in the study area, Tulla sub-city of Hawassa city administration, having lived in the study area for at least 6 month prior to the study and who are planning to continue to be there for the next 1 year. Guardians provide informed consent and the children ascent. ¿ Children with chronic illness like HIVAIDS, tuberculosis, cancer and any other unspecified chronic illness ¿ Severely malnourished children < -3 Z score ¿ Children who are taking iron supplements ¿ Children who got a blood transfusion in the last 6 months Children who are unable to collaborate (any somatic or mental disability making collaboration difficult more than expected for the age range) Children with repeated malaria who are diagnosed as positive for malaria at least 3 times the last 3 months Any suspected hematological disease 24 Month(s) 59 Month(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 15/12/2016 University of Bergen
Ethics Committee Address
Street address City Postal code Country
Gullhaugveien 1-3, 0484 oslo post@helseforskning Norway
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 06/09/2016 Hawassa university institutional review bord
Ethics Committee Address
Street address City Postal code Country
not applicable Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hemoglobin of children and serum ferritin hemoglobin at the beginning, midterm and end of study ferritin at the beginning and end of study
Secondary Outcome anthropometry measures anthropometric measures at the beginning, mid of study ,end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cheffe dato no street address Hawassa not applicable Ethiopia
cheffe cote jewessa no street address Hawassa not applicable Ethiopia
cheffe sedine Hawassa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Hawassa university not applicable Hawassa 1560 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hawassa university not applicable Hawassa 1560 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Hawassa city administretion not applicable Hawassa 1560 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alemselam Orsango zalemselam@yahoo.com +251911000961 not aplicable
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia PhD candidate
Role Name Email Phone Street address
Public Enquiries Lindtjorn Bernt bernt.lindtjorn@cih.uib.no +4795056812 Hordland 5020
City Postal code Country Position/Affiliation
Bergen 7800 Norway Co- supervisor
Role Name Email Phone Street address
Scientific Enquiries Marie Ingunn Ingunn.Engebretsen@uib.no +4797765015 Hordland 5020
City Postal code Country Position/Affiliation
Bergen 7804 Norway Main superviser
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information