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.: PACTR202306743290094 Date of Approval: 12/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pearl millet instant beverage powder enriched with baobab pulp to improve iron and anaemia status of adolescent girls in rural Ghana
Official scientific title Pearl millet instant beverage powder enriched with baobab pulp to improve iron and anaemia status of adolescent girls in rural Ghana
Brief summary describing the background and objectives of the trial Anaemia among adolescent girls in Ghana is a severe public health problem as about half of them are anaemic (GSS et al., 2015). Iron deficiency is the main cause of anaemia among adolescent girls. Food-to-food fortification, which utilizes local available foods, is the most effective and best alternative measure for addressing micronutrient deficiency, as it overcomes the acceptability, sustainability and affordability challenges of the conventional approaches (Teye, 2020). Yet, information on food-to-food fortification interventions for prevention of iron deficiency anaemia among adolescent girls in Ghana is scanty. This study seeks to investigate the efficacy of iron-rich pearl millet beverage powder fortified with vitamin C-rich baobab pulp in improving iron and anaemia status of adolescent girls in rural Ghana
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 Treatment: Other
Anticipated trial start date 22/02/2024
Actual trial start date
Anticipated date of last follow up 30/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 258
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Treatment Treatment to be done five times a week Six months Participants in the intervention group will be given packs containing the pearl millet- baobab pulp composite powder. Each participant will be provided with a cup with the required volume, a teaspoon and the required amount of cold or chill water to be used for the preparation of the beverage. Participants will be fed the beverage five times a week (Monday to Friday) for six consecutive months (including school vacation time). Any leftover from each participant’s cup will be weighed using an electronic kitchen scale and the amount of beverage consumed computed as weight of beverage served minus weight of leftover. 86
Control Group Control group 1 Five times a week Six months Participants in the controlled group 1 will receive packs containing only pearl millet beverage powder (placebo). Each participant will be provided with a cup with the required volume, a teaspoon and the required amount of cold or chill water to be used for the preparation of the beverage. Participants will be fed the beverage five times a week (Monday to Friday) for six consecutive months (including school vacation time). Any leftover from each participant’s cup will be weighed using an electronic kitchen scale and the amount of beverage consumed computed as weight of beverage served minus weight of leftover. 86 Placebo
Control Group Control group 2 One iron-folic acid tablet (60mFe and 0.4mg folate) weekly Six months Participants will receive neither the fortified pearl millet beverage nor the unfortified pearl millet beverage, but the usual iron-folic acid tablets given by Ghana Health Service under the Girls' Iron-Folate Tablet Supplementation Programme 86 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adolescent girls aged 10-19 years • Adolescent girls with mild or moderate anaemia (8< Hb <12 g/dl) • Adolescent girls who consent to participate in the study • Adolescent girls who are pregnant or lactating • Adolescent girls who are on treatment for anaemia • Adolescent girls with severe anaemia (Hb<8 g/dl) • Adolescent girls who are severely underweight (BAZ< -3SD) • Adolescent girls diagnosed with peptic ulcer disease Adolescent: 13 Year-18 Year 10 Year(s) 19 Year(s) Female
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 21/04/2023 Committee on Human Research publication and Ethics
Ethics Committee Address
Street address City Postal code Country
KNUST street Kumasi 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes will be iron and anaemia status of the adolescent girls as measured by the serum ferritin and haemoglobin concentration respectively Endline
Secondary Outcome Secondary outcomes will be prevalence of iron-deficiency, iron-deficiency anaemia, nutrient intake and body mass index. Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kings Primary School kumbungu-Dalun street Kumbungu 00233 Ghana
Dalun RC Primary School Kumbungu-Dalun street Kumbungu 00233 Ghana
Dalun Simli Model Primary School Kumbungu-Dalun street Kumbungu 00233 Ghana
Kanfehiyili Primary School Tamale Kumbungu street Kumbungu 00233 Ghana
Chanzegu DA Junior High School Tamale-Kumbungu street Kumbungu 00233 Ghana
Kpliying Primary School Kanfehiyili-Kpuliying street Kumbungu 00233 Ghana
Kpliying Junior High School Kanfehiyili-Kpuliying street Kumbungu 00233 Ghana
Yelpelnaayili Primary School Tamale-Kumbungu street Kumbungu 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Nestle Foundation 1001 Lausanne Lausanne Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nestle Foundation 1001 Lausanne Lausanne Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ambrose Atosona aatosona@yahoo.com +233246778575 KNUST street
City Postal code Country Position/Affiliation
Kumasi 00233 Ghana PhD Candidate at Kwame Nkrumah University of Science and Technology
Role Name Email Phone Street address
Public Enquiries Charles Apprey appreycharles@gmail.com +233243826275 KNUST
City Postal code Country Position/Affiliation
Kumasi 00233 Ghana Senior Lecturer at Kwame Nkrumah University of Science and Technology
Role Name Email Phone Street address
Scientific Enquiries Christopher Larbie clarbie.cos@knust.edu.gh +233243445961 KNUST
City Postal code Country Position/Affiliation
Kumasi 00233 Ghana Senior Lecturer at Kwame Nkrumah University of Science and Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. Data analysis permitted: individual participant meta-analysis. After 36 months the data will be available in out University’s data warehouse but without investigator support other than deposited metadata.
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