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MalnutritionPhase 2/3ELICITNCT03268902

Early Life Interventions for Childhood Growth and Development In Tanzania

A Phase 2/3 study testing Azithromycin Oral Liquid Product, Nitazoxanide Oral Suspension and Nicotinamide in people with Malnutrition and Stunting, run by Haydom Lutheran Hospital at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 0 to 14 days
Conditions the study is for
Malnutrition, Stunting, Cognitive Development
What is being tested?
Azithromycin Oral Liquid Product, Nitazoxanide Oral Suspension and Nicotinamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,188 participants
Where
1 siteTanzania
Study dates
5 Sep 2017to 26 Mar 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 14 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Maternal age ≥18
  • Infant ≤ 14 days

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Haydom Lutheran Hospital

    Haydom, Manyara Region

Other trials in Tanzania

About this study

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

Read the detailed 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.

Being tested
Azithromycin Oral Liquid Product, Nitazoxanide Oral Suspension, Nicotinamide, Placebos
Medical subject headings
Malnutrition, Growth Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azithromycin Oral Liquid ProductDrug

    Also called Throza DPS

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

  • Nitazoxanide Oral SuspensionDrug

    Also called Alinia

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

  • NicotinamideDietary supplement

    Also called Vitamin B3

    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

  • PlacebosDrug

    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

Study groups in NCT03268902
Study groupRoleWhat they receive
Nicotinamide and AntimicrobialsExperimentalNicotinamide Azithromycin Oral Liquid Product Nitazoxanide Oral Suspension
Receives: Drug: Azithromycin Oral Liquid Product; Drug: Nitazoxanide Oral Suspension; Dietary Supplement: Nicotinamide
Antimicrobials onlyExperimentalPlacebo Azithromycin Oral Liquid Product Nitazoxanide Oral Suspension
Receives: Drug: Azithromycin Oral Liquid Product; Drug: Nitazoxanide Oral Suspension; Drug: Placebos
Nicotinamide onlyExperimentalNicotinamide Placebo Placebo
Receives: Dietary Supplement: Nicotinamide; Drug: Placebos
No active treatmentPlacebo comparatorPlacebo Placebo Placebo
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 18 months

Secondary outcomes (17)

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

    Measured: 18 months

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

    Measured: 18 months

  3. Stunting

    HAZ <-2

    Measured: 18 months

  4. All cause mortality

    Measured: 0-18 months

  5. Hospitalization

    Measured: 0-18 months

  6. Childhood illness

    Incidence of diarrhea, lower respiratory infection and febrile illness

    Measured: 0-18 months

  7. Anemia

    Moderate to severe anemia by WHO definition for age and altitude

    Measured: 12 and 18 months

  8. Enteropathogen burden

    Measured: 6, 6.5, 12, 12.5, 18 months

  9. Microbiota composition

    Composition of intestinal microbiome

    Measured: 6, 6.5, 12, 18 months

  10. Stool myeloperoxidase concentration

    Stool myeloperoxidase ELISA

    Measured: 6, 12, 18 months

  11. C-reactive protein concentration in serum

    High-sensitivity CRP concentration

    Measured: 12 and 18 months

  12. Insulin-like growth factor 1 concentration in serum

    Measured: 12 and 18 months

  13. Collagen X concentration in serum

    Measured: 12 and 18 months

  14. Tryptophan-kynurenine ratio

    Ratio of tryptophan concentration to kynurenine concentration in metabolomic testing

    Measured: 12 and 18 months

  15. Niacin and nicotinamide metabolite concentration

    Concentration of downstream metabolites of niacin and nicotinamide as tested by metabolomic analysis

    Measured: 6, 12, 18 months

  16. Small intestinal bacterial overgrowth

    Prevalence of SIBO as tested via exhaled hydrogen

    Measured: 6, 12 and 18 months

  17. Malawi Developmental Assessment Tool score

    The MDAT is a measure of child cognitive development

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2017
  2. Study start5 Sep 2017
  3. Primary completion28 Feb 2020
  4. Study completion26 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03268902
Sponsor's protocol ID
19465
Acronym
ELICIT
Status last verified
Apr 2021
First submitted
29 Aug 2017
Last updated
10 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • DeBoer MD, McDermid JM, Hampel D, Shahab-Ferdows S, Mazzoni G, Peerson JM, Elwood SE, Scharf RJ, Jatosh S, Platts-Mills JA, Mduma E, Allen LH. Human-milk vitamin B-3 (niacin and vitamer) concentrations: secondary analysis of a randomized, placebo-controlled trial of maternal nicotinamide supplementation in rural Tanzania. Am J Clin Nutr. 2026 Aug;124(2):101397. doi: 10.1016/j.ajcnut.2026.101397. Epub 2026 Jun 17.

    PubMed 42309304

  • 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.

    PubMed 41232946

  • 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.

    PubMed 39032770

  • 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.

    PubMed 36963502

  • 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.

    PubMed 34582462

  • 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.

    PubMed 29982218

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Azithromycin Oral Liquid Product, Nitazoxanide Oral Suspension and Nicotinamide in people with Malnutrition and Stunting, run by Haydom Lutheran Hospital at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Height-for-age z-score (HAZ) at 18 months (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03268902, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

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