Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
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|ClinicalTrials.gov Identifier: NCT01154803|
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : October 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition Malaria Lower Respiratory Tract Infection Diarrhoea||Dietary Supplement: Ready to Use Therapeutic Food (RUTF) Dietary Supplement: Micronutrient Powder (MNP)||Not Applicable|
Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection.
A complete high quality food will be tested, but also micronutrients alone as there is no information on what children with an infection exactly need as a supplement.
Children aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract infection (LRTI) are provided for 2 weeks with
- RUTF supplement (Plumpynut®) of 500 kcal/day
- Multi-micronutrient powder (MNP)
- Placebo to MNP
The followup period is 6 months. Anthropometric indicators and morbidity are assessed monthly. Participants are invited to attend the study clinic if any signs of disease are noticed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2213 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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 Nigeria|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Experimental: Ready to Use Therapeutic Food (RUTF)
500 kcal /day for 2 weeks
Dietary Supplement: Ready to Use Therapeutic Food (RUTF)
1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia)
Other Name: RUTF: Nutriset
Experimental: Micronutrient Powder (MNP)
2 x 1 g sachets micronutrients /day for 2 weeks
Dietary Supplement: Micronutrient Powder (MNP)
2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)
Other Name: MNP: DSM
No Intervention: no supplement
- "negative nutritional outcome" of a child [ Time Frame: 6 months follow-up ]
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.
- Number of new events of a study disease [ Time Frame: 6 months ]study disease: malaria, diarrhoea, and LRTI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154803
|Goronyo health clinic outpatient department|
|Goronyo, Sokoto, Nigeria|
|Principal Investigator:||Saskia Kam van der, Ir||Medecins Sans Frontieres Amsterdam|