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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607534138233 Date of Registration: 30/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Vigna unguiculata (brown beans) gruel on anthropometric and micronutrient status of adolescents (10-19 years) in Aba North Local Government Area of Abia State.
Official scientific title Impact of Vigna unguiculata (brown beans) gruel on anthropometric and micronutrient status of adolescents (10-19 years) in Aba North Local Government Area of Abia State.
Brief summary describing the background and objectives of the trial Adolescence is a phase of life between childhood and adulthood, from ages 10 to 19 (World Health Organization (WHO), 2023). It is a unique and distinct period of human development and an important time for laying the foundation for long term good health (WHO, 2023). Patton, Sawyer, Santelli, Ross and Afifi (2016) classified this period as early adolescence (ages 10–14 years) and late adolescence (ages 15–19 years). There is a strong connection between diet and adolescent growth and this helps in promoting optimal growth and development of adolescents (Norris et al., 2022).Micronutrient is the umbrella term used to represent vitamins and minerals required from the diet to sustain virtually all normal cellular and molecular functions (West, Stewart, Caballero & Black, 2012). A child deficient in micronutrients may be able to go to school and carry on with school activities but the output is far from satisfactory as a result of the consequences of these deficiencies on growth, development, and the entire body physiologic processes (Ayogu & Ona, 2018).Iron, vitamin A and zinc are important micronutrients for growth, development and survival of adolescents, making them micronutrients of global public health importance (Harika, 2017). Deficiency in any of these will increase the prevalence and result in high mortality of adolescents. The broad objective of this study is to evaluate the impact of Vigna unguiculata (brown beans) gruel on anthropometric and micronutrient status of adolescents (10-19 years) in Aba North Local Government Area of Abia State.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) COWGWPAI
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial
Anticipated trial start date 11/01/2024
Actual trial start date 08/04/2024
Anticipated date of last follow up 03/11/2025
Actual Last follow-up date 19/12/2025
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants) 112
Recruitment status Completed
Publication URL Not yet published
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Food based intervention using cowpea gruel and wheat potato biscuit for adolescents with anaemia Participants in the intervention group received cowpea gruel and wheat–potato biscuits in standardized portions. Each participant in experimental group consumed one serving of cowpea gruel daily and a fixed number of wheat–potato biscuits per day for 6 weeks under supervision in the school setting depending on their age and sex 6 weeks The intervention consisted of dietary supplementation using cowpea gruel and wheat–potato biscuits administered to adolescents in the experimental group. Participants consumed one serving of cowpea gruel daily and a fixed number of wheat–potato biscuits under school supervision for a period of 6 weeks in the school setting depending on their age and sex. The intervention was designed to improve haemoglobin concentration, micronutrient status (iron, vitamin A, and zinc), and anthropometric indices among adolescents. Baseline and post-intervention assessments were conducted for haemoglobin, serum ferritin, serum retinol, serum zinc, C-reactive protein and anthropometric indices. 56
Control Group Food based intervention using only wheat potato biscuit for adolescents without anaemia Participants in the intervention group received wheat–potato biscuits only in standardized portions. Each participant in control group consumed one serving of wheat potato biscuits daily per day for 6 weeks under supervision in the school setting depending on their age and sex 6 weeks The intervention consisted of dietary supplementation using wheat–potato biscuits only administered to adolescents in the control group. Participants consumed one serving of wheat–potato biscuits daily under school supervision for a period of 6 weeks in the school setting depending on their age and sex. The intervention was designed to see if haemoglobin concentration, micronutrient status (iron, vitamin A, and zinc), and anthropometric indices among adolescents will improve without consuming cowpea gruel. Baseline and post-intervention assessments were conducted for haemoglobin, serum ferritin, serum retinol, serum zinc, C-reactive protein and anthropometric indices. 56 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The selection of the subjects for human study will be done after conducting the haemoglobin test using only subjects with low haemoglobin were used for the study All subject with normal haemoglobin were not used except for control group. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 10 Year(s) 19 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 11/06/2024 Federal Medical Centre Umuahia
Ethics Committee Address
Street address City Postal code Country
P.M.B 7001, Umuahia, Abia State Nigeria Umuahia 440001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome is the haemoglobin measurment which was taken before and after the intervention study. Baseline and 6 weeks after intervention
Secondary Outcome Secondary Outcome were the serum ferritin, serum retinol, serum zinc and C-reactive protein. Blood samples of the selected adolescents were taken before and after the intervention study. Also anthropometric Measurement were taken to measure HAZ, BAZ, and MUAC before and after the intervention study inorder to assess the impact of the feeding on adolescents. Baseline and 6 weeks after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Government Secondary School in Aba North. Girls Technical College Umuola, Boys Technical College Faulk Road Aba and Osusu Secondary School Osusu Road Aba Aba North Local Government Area Of Abia State 450221 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Chinyere Ogechi 14 Nkumeh Crescent Dubic Road off up Ogbor Hill Aba, Abia State Aba 450001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MR Ogbonna Ogechi Hillary 14 Nkumeh Crescent Dubic Road off 7Up Ogbor Hill Aba, Abia State Nigeria Aba 450001 Nigeria Spouse
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rufina Ayogu rufina.ayugu@unn.edu.ng +2348063293183 Department Of Nutrition and Dietetic, Faculty of Agriculture, University of Nigeria Nsukka, Enugu State
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Professor of Community and Public Health Nutrition in Nutrition and Dietetics Department University of Nigeria Nsukka.
Role Name Email Phone Street address
Public Enquiries Chinyere Ogechi chichioge2010@gmail.com +23480384401 14 Nkumeh Crescent Dubic Road off7up Ogbor Hill Aba
City Postal code Country Position/Affiliation
Aba 450001 Nigeria Student In Nutrition and Dietetic Department University of Nigeria Nsukka
Role Name Email Phone Street address
Scientific Enquiries Arinzechukwu Okpara ndewofc@gmail.com +2348037801111 38 Agu Road Aba Abia State
City Postal code Country Position/Affiliation
Aba 450001 Nigeria Data Analyst
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected include demographic information, dietary intervention allocation, baseline and post-intervention haemoglobin levels, serum ferritin, serum retinol, serum zinc, and C-reactive protein measurements. Data were collected at baseline and after 6 weeks of intervention across the participating schools. Any shared dataset will be de-identified to protect participant Informed Consent Form,Statistical Analysis Plan,Study Protocol After Publication Data available upon reasonable request for academic and research purposes, subject to ethical approval and data-sharing agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet available 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 19/07/2026 Changed from Capital letter to small letter IMPACT OF VIGNA UNGUICULATA (BROWN BEANS) GRUEL ON ANTHROPOMETRIC AND MICRONUTRIENT STATUS OF ADOLESCENTS (10-19 YEARS) INABA NORTH LOCAL GOVERNMENT AREA ABIA STATE Impact of Vigna unguiculata (brown beans) gruel on anthropometric and micronutrient status of adolescents (10-19 years) in Aba North Local Government Area of Abia State.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 19/07/2026 Changed from Capital letter to small letter IMPACT OF VIGNA UNGUICULATA (BROWN BEANS) GRUEL ON ANTHROPOMETRIC AND MICRONUTRIENT STATUS OF ADOLESCENTS (10-19 YEARS) INABA NORTH LOCAL GOVERNMENT AREA ABIA STATE Impact of Vigna unguiculata (brown beans) gruel on anthropometric and micronutrient status of adolescents (10-19 years) in Aba North Local Government Area of Abia State.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 19/07/2026 It has to do with intervention Treatment: Other Other Interventions
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 19/07/2026 Number of partcipants in the clinical trial 581 112
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 19/07/2026 Number of partcipants in the clinical trial 581 112
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 24/07/2026 Because Adolescents 18years and 19 years were included. Adolescent: 13 Year(s)-17 Year(s) Adolescent: 13 Year(s)-17 Year(s), Adult: 18 Year(s)-44 Year(s)