Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight

Malaria Clinical Trial

Official title:

The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819858
• Other study ID #: MSF-nutcon01
• Status: Completed
• Phase: N/A
• First received: January 8, 2009
• Last updated: October 15, 2013
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: October 2013
• Source: Medecins Sans Frontieres
• Contact: n/a
• Is FDA regulated: No
• Health authority: Barbados: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine to what extent provision with RUTF will promote catch up growth in children following an acute uncomplicated episode of P. falciparum malaria.

Description:

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.

Children aged 6-59 months presenting with malaria caused by P. falciparum who are provided with a RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks will show significantly better catch up growth compared to a similar patient group not provided with RUTF (at 2 weeks and 4 weeks post-intervention).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• Age 6 to 59 months, and

• Positive rapid diagnostic test (Paracheck®) and

• Thick smear showing infection with P. falciparum and

• Informed consent from parents or guardian aged at least 18 years.

Exclusion Criteria:

• Children who are exclusively breast fed or

• Children who are severely malnourished (MUAC <110 mm and/or bilateral oedema, or WHO weight-for-Height criteria <3 Z-scores) or

• Presence of general danger signs or signs of severe malaria as defined by the WHO criteria, or

• Known history of allergy to malaria drugs, or

• Having a sibling enrolled in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Convalescence
• Malaria
• Weight Gain
• Weight Loss

Intervention

Dietary Supplement:
• RUTF (Plumpynut®)
Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement

Locations

Country	Name	City	State
Congo	Central Hospital	Dubie	Katanga

Sponsors (1)

Lead Sponsor	Collaborator
Medecins Sans Frontieres

Country where clinical trial is conducted

Congo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain		14 days	No
Secondary	weight gain		28 days	No

External Links

•   abstract symposium: scientific day MSF UK 2009 june 11