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Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01154803
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
Saskia van der Kam, Medecins Sans Frontieres, Netherlands

Brief Summary:
The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.

Condition or disease Intervention/treatment Phase
Malnutrition Malaria Lower Respiratory Tract Infection Diarrhoea Dietary Supplement: Ready to Use Therapeutic Food (RUTF) Dietary Supplement: Micronutrient Powder (MNP) Not Applicable

Detailed Description:

Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection.

A complete high quality food will be tested, but also micronutrients alone as there is no information on what children with an infection exactly need as a supplement.

Children aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract infection (LRTI) are provided for 2 weeks with

  • RUTF supplement (Plumpynut®) of 500 kcal/day
  • Multi-micronutrient powder (MNP)
  • Placebo to MNP

The followup period is 6 months. Anthropometric indicators and morbidity are assessed monthly. Participants are invited to attend the study clinic if any signs of disease are noticed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Nigeria
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ready to Use Therapeutic Food (RUTF)
500 kcal /day for 2 weeks
Dietary Supplement: Ready to Use Therapeutic Food (RUTF)
1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia)
Other Name: RUTF: Nutriset

Experimental: Micronutrient Powder (MNP)
2 x 1 g sachets micronutrients /day for 2 weeks
Dietary Supplement: Micronutrient Powder (MNP)
2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)
Other Name: MNP: DSM

No Intervention: no supplement
no supplementation

Primary Outcome Measures :
  1. "negative nutritional outcome" of a child [ Time Frame: 6 months follow-up ]

    The incidence of a negative nutritional outcome will be defined in two different ways according to the baseline nutritional status.

    i) for children with no malnourishment at time of entry into study, "negative nutritional outcome" is defined as progression to moderate or severe malnourishment ii) for children with moderate malnourishment at time of entry into study, "negative nutritional outcome" is defined as loss of ³10% of baseline weight or progression to severe malnourishment, whichever is reached first.

Secondary Outcome Measures :
  1. Number of new events of a study disease [ Time Frame: 6 months ]
    study disease: malaria, diarrhoea, and LRTI

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 6 to 59 months of age
  • Not malnourished or moderately acutely malnourished children
  • Diagnosis of malaria and/or diarrhoea and/or LRTI
  • Intending to remain in area for the duration of the 6 month follow-up
  • Living within approximately 60 minutes walking distance from the clinic
  • Informed consent from a guardian*

Exclusion Criteria:

  • Child is exclusively breastfeeding
  • Child is severely malnourished
  • Presence of 'General Danger Signs'
  • Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
  • Needing hospitalisation for any reason
  • Known history of allergy to the nutritional supplementation
  • Having a sibling enrolled in the study*

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01154803

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Goronyo health clinic outpatient department
Goronyo, Sokoto, Nigeria
Sponsors and Collaborators
Medecins Sans Frontieres, Netherlands
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Principal Investigator: Saskia Kam van der, Ir Medecins Sans Frontieres Amsterdam
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Saskia van der Kam, Ir, Medecins Sans Frontieres, Netherlands Identifier: NCT01154803    
Other Study ID Numbers: MSF-nutcon02
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Keywords provided by Saskia van der Kam, Medecins Sans Frontieres, Netherlands:
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
Child Nutrition Disorders
Protozoan Infections
Parasitic Diseases
Signs and Symptoms, Digestive
Nutrition Disorders
Respiratory Tract Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs