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.: PACTR202309487179676 Date of Approval: 12/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The study focuses on the hospital-based local formulation of dairy legume-based therapeutic food as a strategy for managing severe acute malnutrition among children aged 6 to 59 months.
Official scientific title The study aims to evaluate the nutritional effectiveness of hospital-based locally prepared ready-to-use therapeutic food in comparison to gold standard formulas.
Brief summary describing the background and objectives of the trial Severe Acute Malnutrition remains a grave issue afflicting children under five years old in the northern regions of Ghana. This condition is often linked to increased infections and, in some cases, fatalities (WHO, 2002; WHO, 2013; WHO, 2021). Disturbingly, over ten million children succumb to SAM before reaching their fifth birthday annually (UNICEF, 2018). In developing countries, children under five with SAM require hospitalization, but the concerning case fatality rates range between 30% and 50% (Ashworth et al., 1994). While the WHO's standardized hospital-based management of SAM shows recovery rates of approximately 80% and case fatality rates ranging from 3.4% to 35% (Black et al., 2013, Hossain et al., 2009, Khanum et al., 1998), only a small fraction of SAM-affected children are currently receiving effective treatment. To address the situation, locally produced Ready-to-Use Therapeutic Food (RUTF) has been employed for the past two years in select northern Ghana hospitals. This shift has become necessary due to the constraints faced by UNICEF in providing therapeutic formulas, caused by the Covid-19 pandemic and various conflicts, including the Ukrainian war. These challenges have led to escalating prices and persistent shortages of therapeutic supplies, significantly impacting the management of hospitalized SAM cases (UNICEF, 2022; WHO, 2002). The typical approach to managing SAM relies on therapeutic formulas that supply essential nutrients for weight gain and recovery. Although standard RUTF has proven effective, it encounters obstacles related to accessibility and availability. In numerous healthcare settings, locally prepared RUTF offers potential advantages by utilizing locally sourced ingredients and aligning with cultural preferences. Secondary data from Tamale Teaching Hospital (TTH) and Kings Medical Centre (KMC) show promising recovery rates of 78% and 83%, respectively, with the usage of local RUTF. Despite adherence to WHO procedures for local RUTF preparation and positive outcomes, there exists a gap in experimental research comparing its nutritional efficacy to the standard formulation in Ghana, particularly in the northern region. As a result, there is a dearth of evidence comparing the effectiveness of locally prepared RUTF with standard formulas, underscoring the need for further research. This study aims to address this knowledge gap by assessing the nutritional impact of locally prepared RUTF. The findings will contribute to the development of context-specific interventions that are not only accessible and culturally appropriate but also effective. Ultimately, this research endeavours to enhance management strategies for SAM, leading to improved health outcomes for affected children.
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 31/08/2023
Actual trial start date
Anticipated date of last follow up 30/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Locally prepared therapeutic formula Dose will depend on weight of participant i.e. 5kg is equivalent to two sachets of a 92 grams of the formulae. Two months The locally prepared therapeutic formula will follow the guidelines for local preparation by the WHO/UNICEF protocols. Locally produced RUTF particularly is an energy-dense, lipid paste consisting of 25% peanut butter, 28% sugar, 30% full-cream milk, 15% vegetable oil, and 1.4% vitamin and mineral supplement. The RUTF will be packaged in plastic rubbers containing 92 g of the formula i.e. same weight with the standard formula and tie tightly. 70
Control Group standard therapeutic formula 5 kg is equivalent to two sachet of a 92 grams of standard formula Two months The standard formulation contains peanut paste, sugar, non-fat dried milk, vegetable oil, a premix containing concentrated minerals and vitamins, and an emulsifier. This will be administered to SAM children for two months and data will be collected at base line and end line. The primary outcome will be recovery (defined as MUAC≥ 12.5 cm, medical complications resolved/resolving and WHZ≥−2 SD of the WHO standards and reduced/absence of oedema of feet). Secondary outcomes included weight gain, length/height gain, LOS, prevalence of diarrhoea, WFH, WFA, HFA and mortality. Also iron, zinc and vitamin A will be assessed including analysis of total protein, albumin, C-reactive protein as well as pro-inflammatory cytokines. 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
SAM children between 6–59 months without allergies to milk or legumes (i.e. peanut) Children admitted at the ward Stable SAM cases Children will be excluded if they are involved in another research trial or feeding program Children with chronic debilitating illness (e.g., cerebral palsy or congenital malformations) Children with history of peanut or milk allergy. Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 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 11/08/2023 Committee on Human Research and Publications Ethics Kwame Nkrumah University of Science and Technology
Ethics Committee Address
Street address City Postal code Country
School of Medicine and Dentistry Street Kumasi-Ghana 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be recovery (defined as MUAC≥ 12.5 cm, medical complications resolved/resolving and WHZ≥−2 SD of the WHO standards and reduced/absence of oedema of feet). To be measured at both base line and end line
Secondary Outcome Secondary outcomes included weight gain, length/height gain, LOS, prevalence of diarrhoea, WFH, WFA, HFA and mortality. Also iron, zinc and vitamin A will be assessed including analysis of total protein, albumin, C-reactive protein as well as pro-inflammatory cytokines. Base line and End line
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tamale Teaching Hospital Kukuo street Tamale 00233 Ghana
King Medical Centre Dalung Road Kumbungu District 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal and Business NA NA 00233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tamimu Yakubu Choggu Hill top street Tamale Metropolis 00233 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Reginald Annan KNUST CoS street Kumasi 00233 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamimu Yakubu yaktammy@gmail.com 02330243887981 Choggu Hill top street , Tamale metropolis
City Postal code Country Position/Affiliation
Tamale Ghana 00233 Ghana Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Hawa Alhassan hawaalhasan391@gmail.com 002330243197863 Kumbungu street, Biwater junction
City Postal code Country Position/Affiliation
Sagnarigu Municipality 00233 Ghana Secretary
Role Name Email Phone Street address
Scientific Enquiries Tamimu Yakubu yaktammy@gmail.com 00233 Choggu Hill Top, Tamale Metropolis
City Postal code Country Position/Affiliation
Tamale 00233 Ghana Assistant Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Trial Registration: We intend to register the trial with unique identifiers, complying with WHO's International Clinical Trials guidelines. Information Disclosure: The details about our study objectives, design, interventions, and outcome measures will be disclosed. Participant Demographics: Demographic data of participants, including age, gender, and baseline health metrics, will be recorded. Trial Design: The design is described, including randomization, blinding, and allocation concealment methods. Intervention Details: Data about the interventions, such as locally prepared therapeutic foods or gold standard formulas will be made available. Outcome Measures: Primary and secondary outcome measures, their definitions, assessment methods, and time points are clearly defined. Results Reporting: We will present the results, both positive and negative outcomes, with statistical methods and effect size measures. Adverse Events: Adverse events will be reported, including their frequency, severity, and relationship to the intervention. Conclusion: Overall findings of the study will be summarized, highlighting their implications for clinical practice and policy. Data Sharing: We will make data available for further analysis and provide access details. Funding and Conflicts: Funding sources and potential conflicts of interest are disclosed to maintain research integrity. Updates and Amendments: Any changes to this randomised study protocol will be summarized. Contact Information: Contact details for the principal investigator will be included. Regulatory Compliance: Adherence to regulatory requirements and ethical guidelines is emphasized. Informed Consent Form Data available in this document and on request The principal investigator, supervisors and Committee on Human Research Publication and Ethics, Kwame Nkrumah University of Science and Technology (KNUST), will have access to data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information