An interventional study of amoxicillin and Ready-to-use therapeutic food (RUTF) in Malnutrition, sponsored by Washington University School of Medicine. Completed at 1 site in Sierra Leone. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2020-09-01.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
This project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling.
This is a cluster-randomized controlled trial taking place in 20 community clinics providing malnutrition care in Sierra Leone.
All participants will be children aged 6-59 months. Control participants will have moderate acute malnutrition (MAM), defined as mid-upper arm circumference (MUAC) 11.5-\<12.5. High Risk MAM will be defined with a MUAC 11.5 to \<11.9 or WAZ\<-3.5 or Mother not the caretaker or not breastfeeding at \<2 years old. Low risk MAM defined with a MUAC 11.9 to \<12.5 with no risk factors.
Control group and low risk group caregiver's will received nutrition education via mother care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks post-enrollment.
High risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of RUTF per day till MUAC is equal to or greater than 12.5 or up to 12 weeks of treatment. Their caregiver will also receive nutrition education via the mother care groups. The investigators will also follow up with the participant at 12 and 24 weeks post-enrollment.
A subset of the participants in each group will also be enrolled in a cognitive development substudy were the investigators will be using a eye tracking performance assessment. Investigators will also enroll health adult participants for eye tracking assessment. Adult data will be used as a reference when interpreting results.
Exclusion Criteria:
MAM children at control clinics or MAM children at intervention clinics that do no have high rick characteristics. Control treatment is "Mother Care" counselling, delivered by a respected elder in the local community.
Behavioral: Mother Care group
The intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed.
Drug: amoxicillin · Dietary Supplement: Ready-to-use therapeutic food (RUTF) · Behavioral: Mother Care group
At enrollment the child will receive a 1 week course of amoxicillin
1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed
Nutrition education via mother care groups lead by a respected elder in the local community
Recovery from moderate acute malnutrition (MAM)
proportion of participants recovered based on mid-upper arm circumference(MUAC) Recovery is defined as MUAC greater than or equal to 12.5cm before or at 12 weeks after enrollment.
Time frame: up to 12 weeks of treatment
Participant survival rates
Proportion of participants survival rates during the study
Time frame: Duration of the study 24 weeks post-enrollment
Participants deterioration to severe acute malnutrition(SAM)
Proportion of participants that deteriorate from moderate acute malnutrition(MAM) to severe acute malnutrition(SAM). SAM is defined at mid-upper arm circumference(MUAC)\<11.5 or presence of oedema.
Time frame: Duration of the study 24 weeks post-enrollment
Participants that remain or become underweight using weight for age z-score
the difference between the weight for age z-score(WAZ) from enrollment to 24 weeks post-enrollment
Time frame: 24 weeks post-enrollment
Participants that remain or become Stunted
the difference between length for age z-score(LAZ) from enrollment to 24 weeks post enrollment
Time frame: 24 weeks post-enrollment
Participants that remain or become Wasted
the difference between weight for length z-score(WHL) from enrollment to 24 weeks post enrollment
Time frame: 24 weeks post-enrollment
Eye tracking performance for cognitive development
the difference between the eye tracking performance from enrollment to 24 weeks post enrollment
Time frame: 24 weeks post enrollment
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine