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Completed

NCT Number: NCT01154803

Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

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.

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Key information

Conditions

Malnutrition Body Weight Convalescence Diarrhea Diarrhoea Disease Attributes Infections Lower Respiratory Tract Infection Malaria Mosquito-Borne Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Signs and Symptoms Signs and Symptoms, Digestive Vector Borne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goronyo health clinic outpatient department

Goronyo, Sokoto State, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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*

Treatment and study plan

Ready to Use Therapeutic Food (RUTF)

Dietary Supplement

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

Micronutrient Powder (MNP)

Dietary Supplement

2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)

Other names: MNP: DSM

Primary outcomes

  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 outcomes

  1. Number of new events of a study disease

    Time frame: 6 months

    study disease: malaria, diarrhoea, and LRTI

Sponsors and collaborators

Lead sponsor

Medecins Sans Frontieres, Netherlands

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2010
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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