Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection. The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 month
Healthy Volunteers: f
View:

• Young infants aged 0-59 days

• Diagnosis of clinical severe infection (CSI)

• Ability to feed enterally

• Intend to stay in the study area for 90 days

• Provided informed consent

Locations
Other Locations
United Republic of Tanzania
Muhimbili University of Health and Allied Sciences
RECRUITING
Dar Es Salaam
Contact Information
Primary
Christopher R Sudfeld, ScD
csudfeld@hsph.harvard.edu
(617) 432-5051
Time Frame
Start Date: 2024-12-27
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 3250
Treatments
Experimental: Zinc Supplementation
14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube
Placebo_comparator: Placebo
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube
Related Therapeutic Areas
Sponsors
Collaborators: Muhimbili University of Health and Allied Sciences
Leads: Harvard School of Public Health (HSPH)

This content was sourced from clinicaltrials.gov

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