Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

October 15, 2013 updated by: Saskia van der Kam, Medecins Sans Frontieres, Netherlands

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Sokoto
      • Goronyo, Sokoto, Nigeria
        • Goronyo health clinic outpatient department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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*

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • MNP: DSM
NO_INTERVENTION: no supplement
no supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"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.
6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of new events of a study disease
Time Frame: 6 months
study disease: malaria, diarrhoea, and LRTI
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medecins Sans Frontieres, Netherlands

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (ESTIMATE)

July 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 15, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSF-nutcon02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malnutrition

Clinical Trials on Ready to Use Therapeutic Food (RUTF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe