Status:
COMPLETED
Mesalamine in Environmental Enteropathy
Lead Sponsor:
Kelsey Jones
Collaborating Sponsors:
Imperial College London
Conditions:
Malnutrition
Eligibility:
All Genders
1-5 years
Phase:
PHASE1
PHASE2
Brief Summary
Undernutrition is one of the most important health issues in Kenya. Children who are chronically undernourished do not reach their full potential and are at increased risk of infectious disease. Stunt...
Eligibility Criteria
Inclusion
- Children aged 1 to 5 years old.
- Provision of informed consent by parent or guardian.
- Stunting (height for age z score \<-2)
- Severe malnutrition (one or more of mid-upper arm circumference \<11.5cm, weight for height z score \<-3, or nutritional oedema).
- Eligible for outpatient management of malnutrition (i.e. no evidence of acute infection, and passes 'appetite test' according to national guidelines).
- Evidence of chronic inflammation (elevated erythrocyte sedimentation rate, ESR \>20mm/hr).
Exclusion
- Known HIV disease or tuberculosis.
- Known previous renal disease or asthma.
- Known allergy or hypersensitivity to mesalamine, other salicylate drugs, or any of the product ingredients.
- Biochemical evidence of acute renal or hepatic impairment on screening blood tests.
- Thrombocytopenia
- Recent (previous two weeks) bloody diarrhoea.
- Concurrent medication known to interact with the study drug (non-steroidal anti-inflammatory drugs, ranitidine, proton-pump inhibitors)
- Acute infection requiring treatment, e.g. lower respiratory tract infection or febrile illness.
- Other reason at the discretion of the attending clinician (independent of the trial team).
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01841099
Start Date
June 1 2013
End Date
May 1 2014
Last Update
July 11 2014
Active Locations (1)
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1
Baraka Clinic
Nairobi, Mathare, Kenya