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.: PACTR202301842318423 Date of Approval: 30/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Turkey Berry Fortified Cookies on Hemoglobin, Hematinic Minerals, Anthropometry and Cognitive Performance among Adolescent Females in School: A Cluster Randomized Controlled Trial in Ghana
Official scientific title Effect of Turkey Berry Fortified Cookies on Hemoglobin, Hematinic Minerals, Anthropometry and Cognitive Performance among Adolescent Females in School: A Cluster Randomized Controlled Trial in Ghana
Brief summary describing the background and objectives of the trial Iron deficiency anemia (IDA) is the greatest cause of morbidity and mortality in adolescent females globally. Anemia affects about 50% of adolescent females in sub-Saharan Africa, the majority of which are caused by iron-deficiency, and can negatively impact the overall growth, cognitive performance, and productivity of schoolchildren. Interventions are needed to address IDA particularly in Ghana, with an emphasis on those that are sustainable, locally available and culturally acceptable. The objective of this trial is to measure the impact of consumption of turkey-berry fortified cookies among female adolescents on hemoglobin, as well as hematinic minerals, cognitive performance, anthropometric measurements.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 06/02/2023
Actual trial start date
Anticipated date of last follow up 06/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1050
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Single Wheat Cookie Without any Supplement Five days per week Six weeks Participants in this arm will receive a wheat cookie without any supplement, five days a week for six weeks. 350 Placebo
Experimental Group Double Turkey Berry Supplemented Cookie Five days per week Six weeks Participants in this arm will receive two turkey berry supplemented cookies, five days a week for six weeks. 350
Experimental Group Single Turkey Berry Supplemented Cookie Five days per week Six weeks Participants in this arm will receive a single turkey berry supplemented cookie, five days a week for six weeks. 350
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Female 2. Aged 10-19 years 3. Assent from participants 4. Informed consent of parent or guardian 1. Participants having taken iron/folate tablets or any hematinic within the three months prior to the study 2. History of a chronic blood disorder, such as sickle-cell disease 3. Participants with known allergies to any of the ingredients utilized in the study 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 13/01/2023 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
School of Medical Sciences KNUST Kumasi 0000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemoglobin levels as assessed by capillary blood sampling 0 weeks, 3 weeks, 6 weeks. Post-trial follow up at 3 months, 6 months, and 12 months post-trial as funding permits.
Secondary Outcome Cognitive assessment via Ravens Coloured Progressive Matrices 0 weeks, 3 weeks, 6 weeks. Post-trial follow up at 3 months, 6 months, and 12 months post-trial as funding permits.
Secondary Outcome Zinc and copper levels as assessed by hair sampling 0 weeks, 6 weeks. Post-trial follow up at 6 months, and 12 months post-trial as funding permits.
Secondary Outcome Nutritional status and dietary intake using anthropometric measurements (weight, height, body fat, visceral fat, muscle mass, mid upper arm circumference, hand grip strength), 24-hour dietary recall and dietary diversity scores at baseline. 0 weeks, 3 weeks, 6 weeks. Post-trial follow up at 3 months, 6 months, and 12 months post-trial as funding permits.
Secondary Outcome Assessment of patient-perceived fatigue using a modified 11-item PERFORM questionnaire. Utilized under the Creative Commons Attribution Noncommercial License. Attribution. Gascón P, Rodríguez CA, Valentín V, Mata JG, Carulla J, Cassinello J, Colomer R, Baró E. Usefulness of the PERFORM questionnaire to measure fatigue in cancer patients with anemia: a prospective, observational study. Support Care Cancer. 2013 Nov;21(11):3039-49. doi: 10.1007/s00520-013-1862-z. Epub 2013 Jun 22. PMID: 23793142; PMCID: PMC3789890. 0 weeks, 3 weeks, 6 weeks. Post-trial follow up at 3 months, 6 months, and 12 months post-trial as funding permits.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kwame Nkrumah University of Science and Technology Department of Biochemistry and Biotechnology Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Big Ideas Blum Center for Developing Economies Blum Center for Developing Economies Berkeley 94720 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Marina Tandoh KNUST Department of Biochemistry Kumasi Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Daniel Haik Big Ideas Blum Center for Developing Economies Berkeley United States of America
Veronica Annaful KNUST Department of Biochemistry Kumasi Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marina Tandoh marinatandoh@knust.edu.gh +233248989545 KNUST Department of Biochemistry
City Postal code Country Position/Affiliation
Kumasi Ghana Lecturer
Role Name Email Phone Street address
Public Enquiries Marina Tandoh marinatandoh@knust.edu.gh +233248989545 KNUST Department of Biochemistry
City Postal code Country Position/Affiliation
Kumasi Ghana Lecturer
Role Name Email Phone Street address
Scientific Enquiries Marina Tandoh marinatandoh@knust.edu.gh +233248989545 KNUST Department of Biochemistry
City Postal code Country Position/Affiliation
Kumasi Ghana Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be available after de-identification. Informed Consent Form,Statistical Analysis Plan,Study Protocol Documents and data will be available 6 months after publication to 2 years Those requesting data to further research this topic, and who will not use the data collected for commercial purposes.
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