Early Life Interventions for Childhood Growth & Development In Tanzania

Status Completed

Clinical Trial Summary

This study aims to assess growth and cognitive effects of treatment with azithromycin and nitazoxanide and/or nicotinamide (vitamin B3) supplementation nicotinamide.

Clinical Trial Description

Children living in rural sub-Saharan Africa experience massive challenges to child thriving, with poor linear growth and delays in child development. In a cohort of 211 children living in the rural Haydom area of Tanzania (participating in the Interactions of Malnutrition & Enteric Infections: Consequences for Child Health and Development "MAL-ED" Study), 70.6% had stunted growth at 18 months. This rate of moderate and severe stunting (length-for-age z-score [HAZ] <-2 standard deviations) was the highest of the 8 study sites in MAL-ED. This enormous deficit is likely associated with high rates of enteric infections with Campylobacter, E. coli pathotypes, Cryptosporidium, and Giardia, organisms susceptible to azithromycin and/or nitazoxanide. Infections such as these occur frequently in developing areas and are often associated with environmental enteropathy, including ongoing enteric inflammation and loss of enterocyte integrity, leading to possible bacterial translocation and poorer absorption of ingested nutrients. The consequences of these infections, enteric dysfunction and poor nutrient absorption frequently include growth stunting, learning delays, and an overall loss of human capital. Emerging evidence suggests a potential role for the tryptophan-niacin pathway (including the end-product nicotinamide, an isoform of vitamin B3) in decreasing mucosal inflammation and affecting enteral microbiota. At the Tanzania site of MAL-ED, serum levels of tryptophan were related to subsequent linear growth, further suggesting importance of the tryptophan-niacin pathway. What is not clear is whether early childhood growth and development could be improved by targeting enteric infection and the tryptophan-niacin pathway by 1) delivering antibiotics against specific bacteria and/or 2) providing vitamin B3 as nicotinamide/niacinamide. The main analysis will be intention-to-treat but a secondary analysis will be per protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03268902
Study type	Interventional
Source	Haydom Lutheran Hospital
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	September 5, 2017
Completion date	March 26, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04448041` - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Active, not recruiting	`NCT04746664` - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia	N/A
Completed	`NCT04608656` - Livestock for Health Project	N/A
Completed	`NCT06009198` - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan	N/A
Recruiting	`NCT05417672` - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting	`NCT05257980` - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial	N/A
Completed	`NCT03628196` - A Nutrition-Focused QIP in Outpatient Clinics
Completed	`NCT05015647` - Low Protein Diet in CKD Patients at Risk of Malnutrition	N/A
Enrolling by invitation	`NCT04675229` - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting	`NCT04627376` - Multimodal Program for Cancer Related Cachexia Prevention	N/A
Not yet recruiting	`NCT05860556` - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting	`NCT06047054` - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting	`NCT04398836` - Preoperative Nutrition for Crohn's Disease Patients	Phase 3
Not yet recruiting	`NCT04183075` - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture	N/A
Not yet recruiting	`NCT03150927` - Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children	N/A
Recruiting	`NCT03408067` - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients	N/A
Recruiting	`NCT02833740` - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition	N/A
Completed	`NCT02938247` - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake	N/A
Completed	`NCT02938234` - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake	N/A
Completed	`NCT02800616` - The Healthy Elementary School of the Future	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Early Life Interventions for Childhood Growth and Development In Tanzania — ELICIT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms