NCT03683667: JiVitA-6

Protein Plus: Improving Infant Growth Through Diet and Enteric Health

Completed Phase 2, PHASE3 Last updated 5 December 2022

What this trial tests

Phase 2, PHASE3 trial testing Azithromycin Oral Product in Stunting in 5,283 participants. Completed in 24 March 2020.

Timeline

23 September 2018

Primary endpoint
19 March 2020

24 March 2020

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	prevention
Enrollment	5,283
Start date	23 September 2018
Primary completion	19 March 2020
Estimated completion	24 March 2020
Sites	1 location across Bangladesh

Drugs / interventions tested

• Azithromycin Oral Product — full drug profile →
• Placebos — full drug profile →
• Protein Supplement — full drug profile →
• Isocaloric Supplement
• Egg
• Nutrition Education

Conditions studied

• Stunting — all drugs for Stunting →
• Malnutrition; Protein — all drugs for Malnutrition; Protein →
• Enteric Pathogens — all drugs for Enteric Pathogens →
• Campylobacter Infections — all drugs for Campylobacter Infections →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

Adults 3 Months to 6 Months, any sex, with Stunting or Malnutrition; Protein. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antimicrobial Resistance Following Azithromycin Mass Drug Administration: Potential Surveillance Strategies to Assess Public Health Impact.
   Mack I, Sharland M, Berkley JA, Klein N, et al · · 2020 · cited 31× · PMID 31633161 · DOI 10.1093/cid/ciz893
2. An Egg Intervention Improves Ponderal But Not Linear Growth Among Infants 6-12 mo of Age in Rural Bangladesh.
   Pasqualino MM, Shaikh S, Hossain MI, Islam MT, et al · · 2024 · cited 6× · PMID 38759886 · DOI 10.1016/j.tjnut.2024.05.006
3. Household animal ownership is associated with infant animal source food consumption in Bangladesh.
   Pasqualino MM, Shaikh S, Islam MT, Parvin S, et al · · 2023 · cited 6× · PMID 37002659 · DOI 10.1111/mcn.13495
4. Prelacteal feeding is not associated with infant size at 3 months in rural Bangladesh: a prospective cohort study.
   Tong H, Thorne-Lyman A, Palmer AC, Shaikh S, et al · · 2024 · cited 4× · PMID 38413997 · DOI 10.1186/s13006-024-00621-4
5. Protein supplementation delivered alone or in combination with presumptive azithromycin treatment for enteric pathogens did not improve linear growth in Bangladeshi infants: results of a cluster-randomized controlled trial.
   Palmer AC, Hossain MI, Ali H, Ayesha K, et al · · 2025 · cited 3× · PMID 39788294 · DOI 10.1016/j.ajcnut.2024.12.027
6. Mass drug administration trials of azithromycin: an analysis to inform future research and guidelines.
   Kong AC, So AD. · · 2025 · cited 1× · PMID 40691807 · DOI 10.1186/s40249-025-01322-8
7. Geospatial variation and risk factors for malnutrition among postpartum women in rural Bangladesh.
   Bellows AL, Thorne-Lyman AL, Shaikh S, Ali H, et al · · 2026 · PMID 41650113 · DOI 10.1371/journal.pgph.0005726
8. Multidrug-Resistant Escherichia coli Isolated from Stool Samples of Healthy Infants in Rural Bangladeshi Communities.
   Johura FT, Tasnim J, Biswas SR, Islam R, et al · · 2025 · PMID 40359926 · DOI 10.4269/ajtmh.24-0541