Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

• ClinicalTrials.gov Identifier: NCT01154803
• Recruitment Status: Completed
• First Posted: July 1, 2010
• Last Update Posted: October 16, 2013
• Sponsor: Medecins Sans Frontieres, Netherlands
• Information provided by (Responsible Party): Saskia van der Kam, Medecins Sans Frontieres, Netherlands

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

Criteria

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*

Contacts and Locations

Locations

Nigeria

Goronyo health clinic outpatient department

Goronyo, Sokoto, Nigeria

Sponsors and Collaborators

Medecins Sans Frontieres, Netherlands

Investigators

• Principal Investigator: Saskia Kam van der, Ir; Medecins Sans Frontieres Amsterdam

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van der Kam S, Salse-Ubach N, Roll S, Swarthout T, Gayton-Toyoshima S, Jiya NM, Matsumoto A, Shanks L. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Nigeria. PLoS Med. 2016 Feb 9;13(2):e1001952. doi: 10.1371/journal.pmed.1001952. eCollection 2016 Feb.

• Responsible Party: Saskia van der Kam, Ir, Medecins Sans Frontieres, Netherlands
• ClinicalTrials.gov Identifier: NCT01154803
• Other Study ID Numbers: MSF-nutcon02
• First Posted: July 1, 2010
• Last Update Posted: October 16, 2013
• Last Verified: October 2013

Keywords provided by Saskia van der Kam, Medecins Sans Frontieres, Netherlands:

Supplementation; RUTF; Micronutrients; Plumpynut; Mixme; sprinkles; convalescence; weight; morbidity

Additional relevant MeSH terms:

Infection; Communicable Diseases; Respiratory Tract Infections; Malaria; Malnutrition; Child Nutrition Disorders; Diarrhea; Protozoan Infections; Parasitic Diseases; Signs and Symptoms, Digestive; Nutrition Disorders; Respiratory Tract Diseases; Micronutrients; Trace Elements; Nutrients; Growth Substances; Physiological Effects of Drugs