Early Life Interventions for Childhood Growth and Development In Tanzania

NCT03268902 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 19465
• Study Type: interventional
• Target: 1,188
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malnutrition; Stunting; Cognitive Development; Enteric Pathogens

Outcome Measures

Primary Outcomes (1)

• Height-for-age z-score (HAZ) at 18 months

  18 months

Secondary Outcomes (17)

• Weight-for-age z-score (WAZ) at 18 months

  18 months

• Head circumference-for-age z-score (HCAZ) at 18 months

  18 months

• Stunting

  18 months

• All cause mortality

  0-18 months

• Hospitalization

  0-18 months

Study Arms (4)

Nicotinamide and Antimicrobials

EXPERIMENTAL

Nicotinamide Azithromycin Oral Liquid Product Nitazoxanide Oral Suspension

Drug: Azithromycin Oral Liquid Product; Drug: Nitazoxanide Oral Suspension; Dietary Supplement: Nicotinamide

Antimicrobials only

EXPERIMENTAL

Placebo Azithromycin Oral Liquid Product Nitazoxanide Oral Suspension

Drug: Azithromycin Oral Liquid Product; Drug: Nitazoxanide Oral Suspension; Drug: Placebos

Nicotinamide only

EXPERIMENTAL

Nicotinamide Placebo Placebo

Dietary Supplement: Nicotinamide; Drug: Placebos

No active treatment

PLACEBO COMPARATOR

Placebo Placebo Placebo

Drug: Placebos

Interventions

Azithromycin Oral Liquid Product DRUG

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

Also known as: Throza DPS

Antimicrobials only; Nicotinamide and Antimicrobials

Nitazoxanide Oral Suspension DRUG

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

Also known as: Alinia

Antimicrobials only; Nicotinamide and Antimicrobials

Nicotinamide 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

Also known as: Vitamin B3

Nicotinamide and Antimicrobials; Nicotinamide only

Placebos 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

Antimicrobials only; Nicotinamide only; No active treatment

Eligibility Criteria

• Age: 0 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Maternal age ≥18
• Infant ≤ 14 days

You may not qualify if:

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

Sponsors & Collaborators

• Haydom Lutheran Hospital: lead
• University of Virginia: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Haydom Lutheran Hospital

Haydom, Manyara Region, Tanzania

Location

Related Publications (5)

• DeBoer MD, Elwood SE, Guga G, Jatosh S, Scharf RJ, Liu J, Rogawski McQuade ET, Mduma ER, Houpt E, Platts-Mills JA. Enteric pathogen carriage in early childhood is associated with elevated CRP, lower IGF-1 and linear growth deficits: the ELICIT study in rural Tanzania. BMJ Glob Health. 2025 Nov 12;10(11):e018454. doi: 10.1136/bmjgh-2024-018454.

  PMID: 41232946 DERIVED

• Parpia T, Elwood S, Rogawski McQuade ET, Svensen E, Wanjuhi A, Jatosh S, Bayo E, Hhando E, Houpt ER, Mduma E, DeBoer MD, Scharf RJ, Platts-Mills JA. Growth and Cognitive Development in Tanzanian Children are Associated with Timing of Birth in Relation to Seasonal Malnutrition. J Pediatr. 2024 Dec;275:114202. doi: 10.1016/j.jpeds.2024.114202. Epub 2024 Jul 19.

  PMID: 39032770 DERIVED

• DeBoer MD, Elwood SE, Platts-Mills JA, McDermid JM, Scharf RJ, Rogawski McQuade ET, Jatosh S, Houpt ER, Mduma E. Association of Circulating Biomarkers with Growth and Cognitive Development in Rural Tanzania: A Secondary Analysis of the Early Life Interventions in Childhood Growth and Development In Tanzania (ELICIT) Study. J Nutr. 2023 May;153(5):1453-1460. doi: 10.1016/j.tjnut.2023.03.020. Epub 2023 Mar 22.

  PMID: 36963502 DERIVED

• DeBoer MD, Platts-Mills JA, Elwood SE, Scharf RJ, McDermid JM, Wanjuhi AW, Jatosh S, Katengu S, Parpia TC, Rogawski McQuade ET, Gratz J, Svensen E, Swann JR, Donowitz JR, Mdoe P, Kivuyo S, Houpt ER, Mduma E. Effect of scheduled antimicrobial and nicotinamide treatment on linear growth in children in rural Tanzania: A factorial randomized, double-blind, placebo-controlled trial. PLoS Med. 2021 Sep 28;18(9):e1003617. doi: 10.1371/journal.pmed.1003617. eCollection 2021 Sep.

  PMID: 34582462 DERIVED

• DeBoer MD, Platts-Mills JA, Scharf RJ, McDermid JM, Wanjuhi AW, Gratz J, Svensen E, Swann JR, Donowitz JR, Jatosh S, Houpt ER, Mduma E. Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT): a protocol for a randomised factorial, double-blind, placebo-controlled trial of azithromycin, nitazoxanide and nicotinamide. BMJ Open. 2018 Jul 7;8(7):e021817. doi: 10.1136/bmjopen-2018-021817.

  PMID: 29982218 DERIVED

MeSH Terms

Conditions

Malnutrition; Growth Disorders

Interventions

nitazoxanide; Niacinamide

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Estomih Mduma

  Haydom Lutheran Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and investigators will be blinded to the treatments allocated to each participant. The members of the DSMB will also be blinded.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: September 5, 2017
• Primary Completion: February 28, 2020
• Study Completion: March 26, 2020
• Last Updated: May 10, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)