NCT01497236

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

June 30, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

December 20, 2011

Last Update Submit

June 29, 2015

Conditions

Child MalnutritionInfant Morbidity

Outcome Measures

Primary Outcomes (1)

  • "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 Outcomes (1)

  • Number of new events of a study disease

    6 months

Study Arms (3)

Experimental: Ready to Use Terapeutic Food (RUTF)

EXPERIMENTAL
Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP

Multi Micronutrient Powder (MNP)

EXPERIMENTAL
Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP

no supplement

NO INTERVENTION

Interventions

Dietary Supplement: Nutrition supplement with RUTF or MNPDIETARY_SUPPLEMENT

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

Also known as: Other Names:, RUTF: Nutriset, MNP: MixMe, DSM, Placebo: DSM
Experimental: Ready to Use Terapeutic Food (RUTF)Multi Micronutrient Powder (MNP)

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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\*

You may not qualify if:

  • 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\*

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaabong Hospital

Kaabong, Karamoja District, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 26859481DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Nuria Salse

    MSF Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutrition Advisor MSF Spain

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 30, 2015

Record last verified: 2015-06

Locations

UG(1)