Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154803
• Other study ID #: MSF-nutcon02
• Status: Completed
• Phase: N/A
• First received: June 30, 2010
• Last updated: October 15, 2013
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2013
• Source: Medecins Sans Frontieres
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Médecins Sans FrontièresNigeria: Ministry of Health, Sokoto state, Nigeria
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2213
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Diarrhea
• Diarrhoea
• Infection
• Lower Respiratory Tract Infection
• Malaria
• Malnutrition
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
Nigeria	Goronyo health clinic outpatient department	Goronyo	Sokoto

Sponsors (1)

Lead Sponsor	Collaborator
Medecins Sans Frontieres

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"negative nutritional outcome" of a child	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	No
Secondary	Number of new events of a study disease	study disease: malaria, diarrhoea, and LRTI	6 months	No