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Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Saskia van der Kam, Medecins Sans Frontieres
ClinicalTrials.gov Identifier:
NCT01154803
First received: June 30, 2010
Last updated: October 4, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Malnutrition
Malaria
Lower Respiratory Tract Infection
Diarrhoea
 Dietary Supplement: Nutrition supplement with RUTF or MNP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medecins Sans Frontieres:

Primary Outcome Measures:
  • "negative nutritional outcome" of a child [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

    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:
  • Number of new events of a study disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    study disease: malaria, diarrhoea, and LRTI


Estimated Enrollment: 2160
Study Start Date: February 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ready to Use Terapeutic Food (RUTF) Dietary Supplement: Nutrition supplement with RUTF or MNP

14 days nutritional supplementation with either

  • a fortified high quality food(RUTF), 1 sachet/day, 500 kcal and multi micronutrients
  • a multi micronutrient powder (MNP), 2 sachets per day, no calories, twice recommended daily intake
  • a placebo (to MNP), 2 sachets per day , no calories, no micronutrients, containing micronutrient carrier
Other Names:
  • RUTF: Nutriset
  • MNP: MixMe, DSM
  • Placebo: DSM
Experimental: Multi Micronutrient Powder (MNP) Dietary Supplement: Nutrition supplement with RUTF or MNP

14 days nutritional supplementation with either

  • a fortified high quality food(RUTF), 1 sachet/day, 500 kcal and multi micronutrients
  • a multi micronutrient powder (MNP), 2 sachets per day, no calories, twice recommended daily intake
  • a placebo (to MNP), 2 sachets per day , no calories, no micronutrients, containing micronutrient carrier
Other Names:
  • RUTF: Nutriset
  • MNP: MixMe, DSM
  • Placebo: DSM
No Intervention: no supplement

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.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154803

Locations
Nigeria
Goronyo health clinic outpatient department
Goronyo, Sokoto, Nigeria
Sponsors and Collaborators
Medecins Sans Frontieres
Investigators
Principal Investigator: Saskia Kam van der, Ir Medecins Sans Frontieres Amsterdam
  More Information

No publications provided

Responsible Party: Saskia van der Kam, Ir, Medecins Sans Frontieres
ClinicalTrials.gov Identifier: NCT01154803     History of Changes
Other Study ID Numbers: MSF-nutcon02
Study First Received: June 30, 2010
Last Updated: October 4, 2012
Health Authority: The Netherlands: Médecins Sans Frontières
Nigeria: Ministry of Health, Sokoto state, Nigeria

Keywords provided by Medecins Sans Frontieres:
Supplementation
RUTF
Micronutrients
Plumpynut
Mixme
 sprinkles
convalescence
weight
morbidity

Additional relevant MeSH terms:
Diarrhea
Malaria
Respiratory Tract Infections
Malnutrition
Child Nutrition Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Protozoan Infections
Parasitic Diseases
 Infection
Respiratory Tract Diseases
Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013