Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda

Child Malnutrition Clinical Trial

— MSF-nutcon03  

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 Kaabong, Karamoja, Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497236
• Other study ID #: MSF-nutcon03
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: June 29, 2015
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: June 2015
• Source: Medecins Sans Frontieres, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• 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:

similar to MSF-nutcon 03 : NCT01154803

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2202
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• 6 to 59 months of age

• Not malnourished

• 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 Malnutrition
• Child Nutrition Disorders
• Infant Morbidity
• Malnutrition

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Uganda	Kaabong Hospital	Kaabong	Karamoja district

Sponsors (1)

Lead Sponsor	Collaborator
Medecins Sans Frontieres, Spain

Country where clinical trial is conducted

Uganda, 

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