Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children (MODMAL)

This study has been terminated.
(New provision of supplementary feeds for moderately malnourished children in the study area.)
Sponsor:
Information provided by (Responsible Party):
Jay Berkley, University of Oxford
ClinicalTrials.gov Identifier:
NCT00890695
First received: April 29, 2009
Last updated: June 17, 2013
Last verified: June 2013
Results First Received: January 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Malnutrition
Infection
Intervention: Dietary Supplement: Ready to Use Supplementary Food (RUSF)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was started on June 5 2009 and finished on October 8 2009. The study was terminated early because of an inadequate recruitment rate and because a donor-funded supplementary feeding programme targeting moderately malnourished children was started in September 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 7,132 sick children aged 6 months to 5 years seen in outpatients during the study period, 190 with a mid upper arm circumference (MUAC) <12.5cm were assessed for eligibility. Randomization was carried out on 65 children who were eligible and whose carers consented. 1 was withdrawn: weight for height Z score (WHZ) was found to be <-3.

Reporting Groups
  Description
1 Ready to Use Supplementary Food (RUSF)

Products, Kenya. The RUSF composition is in accordance with recommended supplementary feed composition specified by the latest WHO expert consultation in 2008 reported by Golden et al. It is formulated to provide 507 kcal per 100g, 6% protein/energy ratio and 55% fat/energy ratio. Essential fatty acids contained are N-6 (linoleic acid) 6 kcal % and N-3 (o-linoleic) 0.3 kcal %. Vitamin and mineral premix (3%) will provide the currently recommended nutrient intake for moderately malnourished children of minerals (K, Na, Ca, P, Mg, Fe, Zn, Cu, Se, I, Mn, Cr, Mo, F), Vitamins (thiamine, riboflavin, pyridoxine, niacin, Vit B12, folic acid, Vit C, Biotin, Pantothenic acid, Vit A, Vit D,Vit E and Vit K).

initial visit. The amount supplied is based on the child's weight; the recommended energy supplement being 100kcal per kg per day which is equivalent to 25g RUSF per kg per day.

2 Normal Diet For equity, parents or guardians of children in the usual diet arm are given 2 bags of maize meal (4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook.

Participant Flow:   Overall Study
    1 Ready to Use Supplementary Food (RUSF)     2 Normal Diet  
STARTED     32     33  
COMPLETED     31     33  
NOT COMPLETED     1     0  
Protocol Violation                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 RUSF RUSF prescribed for the child for 4 weeks
2 Normal Diet normal diet arm
Total Total of all reporting groups

Baseline Measures
    1 RUSF     2 Normal Diet     Total  
Number of Participants  
[units: participants]
  31     33     64  
Age  
[units: participants]
     
<=18 years     31     33     64  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  1.21  ± 0.55     1.15  ± 0.46     1.18  ± 0.50  
Gender  
[units: participants]
     
Female     26     23     49  
Male     5     10     15  
Region of Enrollment  
[units: participants]
     
Kenya     31     33     64  



  Outcome Measures
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1.  Primary:   Weight for Height z Score at 4 Weeks   [ Time Frame: between enrolment and 4 weeks ]

2.  Secondary:   WHZ Score at 3 Months   [ Time Frame: between enrolment and 3 months ]

3.  Secondary:   MUAC for Age Z Score at 3 Months   [ Time Frame: between enrolment and 4 weeks and at 3 months ]

4.  Secondary:   Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)   [ Time Frame: at 4 weeks and 3 months ]

5.  Secondary:   Anemia (Hb <9.3g/dl)   [ Time Frame: at 4 weeks ]

6.  Secondary:   Hospital Admission or Death   [ Time Frame: from enrolment to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial was forced to stop early, 65 recruited. Analysis was inadequately powered to detect the changes in WHZ score and MUAC, the analysis of which had been originally planned for a sample size of 400.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr James Berkley
Organization: KEMRI/Wellcome Trust Research Programme
phone: +254 41 522535
e-mail: jberkley@kilifi.kemri-wellcome.org


No publications provided


Responsible Party: Jay Berkley, University of Oxford
ClinicalTrials.gov Identifier: NCT00890695     History of Changes
Other Study ID Numbers: SSC 1415
Study First Received: April 29, 2009
Results First Received: January 15, 2013
Last Updated: June 17, 2013
Health Authority: Kenya: Ethical Review Committee