NCT01154803

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
2,213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

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

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

June 30, 2010

Last Update Submit

October 15, 2013

Conditions

MalnutritionMalariaLower Respiratory Tract InfectionDiarrhoea

Keywords

SupplementationRUTFMicronutrientsPlumpynutMixmesprinklesconvalescenceweightmorbidity

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)

Ready to Use Therapeutic Food (RUTF)

EXPERIMENTAL

500 kcal /day for 2 weeks

Dietary Supplement: Ready to Use Therapeutic Food (RUTF)

Micronutrient Powder (MNP)

EXPERIMENTAL

2 x 1 g sachets micronutrients /day for 2 weeks

Dietary Supplement: Micronutrient Powder (MNP)

no supplement

NO INTERVENTION

no supplementation

Interventions

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)

Also known as: RUTF: Nutriset
Ready to Use Therapeutic Food (RUTF)
Micronutrient Powder (MNP)DIETARY_SUPPLEMENT

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

Also known as: MNP: DSM
Micronutrient Powder (MNP)

Eligibility Criteria

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

You may qualify if:

  • 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\*

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)

Goronyo health clinic outpatient department

Goronyo, Sokoto State, Nigeria

Location

Related Publications (1)

  • van der Kam S, Salse-Ubach N, Roll S, Swarthout T, Gayton-Toyoshima S, Jiya NM, Matsumoto A, Shanks L. 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 Nigeria. PLoS Med. 2016 Feb 9;13(2):e1001952. doi: 10.1371/journal.pmed.1001952. eCollection 2016 Feb.

    PMID: 26859559DERIVED

MeSH Terms

Conditions

MalnutritionMalariaDiarrheaConvalescenceBody Weight

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Saskia Kam van der, Ir

    Medecins Sans Frontieres Amsterdam

    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
Ir

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

NG(1)