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.: PACTR201704002119141 Date of Approval: 21/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative analysis of complementary feeds in children with moderate acute malnutrition
Official scientific title Comparative analysis of complementary feeds in children with moderate acute malnutrition: an assessment of effectiveness, tolerability and safety
Brief summary describing the background and objectives of the trial Malnutrition results from qualitative or quantitative deficiency of dietary nutrient. Most cases of childhood malnutrition occur in Asia and Africa and are often associated with poverty, ignorance and concomitant childhood infectious diseases. The condition can be sub-classified into mild, moderate and severe malnutrition in relation to the standard reference values for age and sex based on the World Health Organization classification. Malnutrition leads to impaired physical, immunologic, neurologic and neurologic development. Most malnutrition-related morbidities and mortalities occur in children with moderate acute malnutrition. In the absence of nutritional intervention, children with moderate acute malnutrition could deteriorate to develop severe acute malnutrition. Presently, there is no standardized nutritional formulation for managing moderate acute malnutrition. Different nutritional formulations depending on the geographical locations are being investigated for this condition. This study aims at comparing the effectiveness, tolerability and adverse effect of milk-based nutritional formulation, non-milk based formulation and standard hospital based formulation in the management of children aged 6 months to 35 months with moderate acute malnutrition.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Moderate acute malnutrition in underfives,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 03/06/2016
Actual trial start date 07/06/2016
Anticipated date of last follow up 06/04/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 194
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 randomization by balloting Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Milk based formulation 50% of daily caloric requirement Four months Consist mainly of maize and is rich in methionine 72
Experimental Group Non milk based formulation 50% of daily caloric requirement Four months Consist of maize and soybeans and is rich in methionine and lysine 67
Control Group Hospital-based formulation 50% of caloric requirement of participants Four months Corn cereal fortified with soya beans, vegetable oil, sugar, soya beans and mineral mix 55 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children 6 months to 59 months with moderate acute malnutrition. 2. Children whose parents consented to their participation and agreed to bring them to the health facility during the period of the study. 1. Children with chronic illnesses that may affect growth. 2. Children with feeding difficulties eg. cleft palate. 3. Children with diarrhea. 4. Children with neurologic disorders eg. cerebral palsy. 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 02/03/2016 UNiversity of Uyo Teaching Hospital, Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
332 Abak Road Uyo 520261 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Improvement from baseline of nutritional indices (weight-for-age; height-for-age and weight-for-height) 1. Week 2 2. Week 4 3. Week 6 4. Week 8 5. Week 10 6. Week 12 7. Week 14 8. Week 16 9. Week 18
Secondary Outcome Change in mid upper arm circumference from baseline 1. Week 2 2. Week 4 3. Week 6 4. Week 8 5. Week 10 6. Week 12 7. Week 14 8. Week 16 9. Week 18
Secondary Outcome Time to recovery from MAM 1. Week 2 2. Week 4 3. Week 6 4. Week 8 5. Week 10 6. Week 12 7. Week 14 8. Week 16 9. Week 18
Secondary Outcome Time to recovery from MAM 1. Week 2 2. Week 4 3. Week 6 4. Week 8 5. Week 10 6. Week 12 7. Week 14 8. Week 16 9. Week 18
Secondary Outcome ¿ Change in serum electrolyte, urea and creatinine values from baseline 1. Baseline - week 0 2. Endpoint - week 18
Secondary Outcome ¿ All-cause- mortality Time of death (Any week)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Primary Health Centre, Adadiah Adadiah Uruan Nigeria
Primary Health Centre, Okopediuse Market Road Ibiono Ibom Nigeria
Primary Health Centre, Mbak -Etoi School Road Mbak-Etoi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nestle Nigeria Institute Africa 22/24 Industrial Avenue, Ilupeju Lagos Nigeria
Nestle Nigeria Institute Africa 22/24 Industrial Avenue, Ilupeju Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nestle Nigeria Institute Africa 22/24 Industrial Avenue, Ilupeju Lagos Nigeria Commercial Sector/Industry
Primary Sponsor Nestle Nigeria Institute Africa 22/24 Industrial Avenue, Ilupeju Lagos Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Ms. Blessing Njideka Nwazuluoke 332 Abak Road (Dietetic Department, University of Uyo Teaching Hospital) Uyo 520261 Nigeria
Mr. Victor Effiong Bassey IBB Way (Ministry of Health, Akwa Ibom State) Uyo 520261 Nigeria
Dr (Mrs.) Regina Idu Ejemot-Nwadiaro Etagbor Street, (Public Health Department, University of Calabar) Calabar Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ekong Emmanuel Udoh rejoicerejoice2001@yahoo.com +234(0)8038355559 University of Uyo Teaching Hospital, Uyo
City Postal code Country Position/Affiliation
Uyo 520261 Nigeria Consultant of Paediatric Gastroenterology University of Uyo Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Victor Effiong Bassey vicebassey@yahoo.com +234(0)8023400768 University of Uyo Teaching Hospital, Uyo
City Postal code Country Position/Affiliation
Uyo 520261 Nigeria State Nutrition Officer Akwa Ibom State Ministry Of Health, Uyo
Role Name Email Phone Street address
Scientific Enquiries Blessing Njideka Nwazuluoke blessingnn19@yahoo.com +234(0)8023236758 University of Uyo Teaching Hospital, Uyo
City Postal code Country Position/Affiliation
Uyo 520261 Nigeria Principal Dietician/Dietetic Unit, University of Uyo Teaching Hospital
REPORTING
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