Early Life Interventions for Childhood Growth and Development In Tanzania

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-05

Study Completion Date

2020-03-26

Brief Summary

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

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Detailed Description

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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.

Conditions

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Malnutrition Stunting Cognitive Development Enteric Pathogens

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Each intervention will be assigned independently. Intervention domains will be randomized separately on an individual basis. This will provide 4 different combinations of interventions: 1). Nicotinamide, azithromycin and nitazoxanide 2). Azithromycin and nitazoxanide 3). Nicotinamide only 4). No active treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Both participants and investigators will be blinded to the treatments allocated to each participant. The members of the DSMB will also be blinded.

Study Groups

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Nicotinamide and Antimicrobials

Nicotinamide Azithromycin Oral Liquid Product Nitazoxanide Oral Suspension

Group Type EXPERIMENTAL

Azithromycin Oral Liquid Product

Intervention Type DRUG

Azithromycin 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months

Nitazoxanide Oral Suspension

Intervention Type DRUG

Nitazoxanide 100 mg given twice daily for 3 days at 12 and 15 months

Nicotinamide

Intervention Type DIETARY_SUPPLEMENT

Mothers in the nicotinamide arm will be given nicotinamide 250 mg daily from delivery through 6 months post-partum in capsule form.

Children in the nicotinamide arm will be given 100 mg/d in powder form between 6 and 18 months of age

Antimicrobials only

Placebo Azithromycin Oral Liquid Product Nitazoxanide Oral Suspension

Group Type EXPERIMENTAL

Azithromycin Oral Liquid Product

Intervention Type DRUG

Azithromycin 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months

Nitazoxanide Oral Suspension

Intervention Type DRUG

Nitazoxanide 100 mg given twice daily for 3 days at 12 and 15 months

Placebos

Intervention Type DRUG

Contain inert excipients only. Azithromycin placebo 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months. Nitazoxanide placebo 100 mg given twice daily for 3 days at 12 and 15 months.

Mothers in the nicotinamide placebo arm will be given placebo 250 mg daily from delivery through 6 months post-partum in capsule form.

Children in the nicotinamide placebo arm will be given 100 mg/d of placebo in powder form between 6 and 18 months of age

Nicotinamide only

Nicotinamide Placebo Placebo

Group Type EXPERIMENTAL

Nicotinamide

Intervention Type DIETARY_SUPPLEMENT

Mothers in the nicotinamide arm will be given nicotinamide 250 mg daily from delivery through 6 months post-partum in capsule form.

Children in the nicotinamide arm will be given 100 mg/d in powder form between 6 and 18 months of age

Placebos

Intervention Type DRUG

Contain inert excipients only. Azithromycin placebo 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months. Nitazoxanide placebo 100 mg given twice daily for 3 days at 12 and 15 months.

Mothers in the nicotinamide placebo arm will be given placebo 250 mg daily from delivery through 6 months post-partum in capsule form.

Children in the nicotinamide placebo arm will be given 100 mg/d of placebo in powder form between 6 and 18 months of age

No active treatment

Placebo Placebo Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Contain inert excipients only. Azithromycin placebo 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months. Nitazoxanide placebo 100 mg given twice daily for 3 days at 12 and 15 months.

Mothers in the nicotinamide placebo arm will be given placebo 250 mg daily from delivery through 6 months post-partum in capsule form.

Children in the nicotinamide placebo arm will be given 100 mg/d of placebo in powder form between 6 and 18 months of age

Interventions

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Azithromycin Oral Liquid Product

Azithromycin 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months

Intervention Type DRUG

Nitazoxanide Oral Suspension

Nitazoxanide 100 mg given twice daily for 3 days at 12 and 15 months

Intervention Type DRUG

Nicotinamide

Mothers in the nicotinamide arm will be given nicotinamide 250 mg daily from delivery through 6 months post-partum in capsule form.

Children in the nicotinamide arm will be given 100 mg/d in powder form between 6 and 18 months of age

Intervention Type DIETARY_SUPPLEMENT

Placebos

Contain inert excipients only. Azithromycin placebo 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months. Nitazoxanide placebo 100 mg given twice daily for 3 days at 12 and 15 months.

Mothers in the nicotinamide placebo arm will be given placebo 250 mg daily from delivery through 6 months post-partum in capsule form.

Children in the nicotinamide placebo arm will be given 100 mg/d of placebo in powder form between 6 and 18 months of age

Intervention Type DRUG

Other Intervention Names

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Throza DPS Alinia Vitamin B3

Eligibility Criteria

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Inclusion Criteria

1. Maternal age ≥18
2. Infant ≤ 14 days

Exclusion Criteria

1. Maternal inability to adhere to protocol
2. Multiple gestation
3. Severe illness (significant birth defect, hospitalization, severe neonatal illness)
4. Birth weight \<1500 g
5. Lack of breastfeeding at enrollment (and lack of intention to continue breastfeeding at time of enrollment).

Minimum Eligible Age

0 Days

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No