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

NCT ID: NCT01497236

Last Updated: 2015-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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similar to MSF-nutcon 03 : NCT01154803

Conditions

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Child Malnutrition Infant Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Experimental: Ready to Use Terapeutic Food (RUTF)

Group Type EXPERIMENTAL

Dietary Supplement: Nutrition supplement with RUTF or MNP

Intervention Type DIETARY_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

Multi Micronutrient Powder (MNP)

Group Type EXPERIMENTAL

Dietary Supplement: Nutrition supplement with RUTF or MNP

Intervention Type DIETARY_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

no supplement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Other Names: RUTF: Nutriset MNP: MixMe, DSM Placebo: DSM

Eligibility Criteria

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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\*
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medecins Sans Frontieres, Spain

OTHER

Sponsor Role lead

Responsible Party

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Nuria Salse

Nutrition Advisor MSF Spain

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuria Salse

Role: PRINCIPAL_INVESTIGATOR

MSF Spain

Locations

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Kaabong Hospital

Kaabong, Karamoja District, Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type DERIVED
PMID: 26859481 (View on PubMed)

Other Identifiers

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MSF-nutcon03

Identifier Type: -

Identifier Source: org_study_id

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