Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda (MSF-nutcon03)

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

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: Child Malnutrition; Infant Morbidity
• Intervention / Treatment: Dietary supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP

Detailed Description

similar to MSF-nutcon 03 : NCT01154803

• Study Type: Interventional
• Enrollment (Actual): 2202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Karamoja district
    • Kaabong, Karamoja district, Uganda
      • Kaabong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Ready to Use Terapeutic Food (RUTF)	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; Other Names: Other Names:; RUTF: Nutriset; MNP: MixMe, DSM; Placebo: DSM
Experimental: Multi Micronutrient Powder (MNP)	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; Other Names: Other Names:; RUTF: Nutriset; MNP: MixMe, DSM; Placebo: DSM
No Intervention: no supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medecins Sans Frontieres, Spain
• Investigators: Principal Investigator: Nuria Salse, MSF Spain

Publications and helpful links

General Publications

• van der Kam S, Roll S, Swarthout T, Edyegu-Otelu G, Matsumoto A, Kasujja FX, Casademont C, Shanks L, Salse-Ubach N. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Uganda. PLoS Med. 2016 Feb 9;13(2):e1001951. doi: 10.1371/journal.pmed.1001951. eCollection 2016 Feb.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 22, 2011

Study Record Updates

• Last Update Posted (Estimate): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• Other Study ID Numbers: MSF-nutcon03