Zinc Supplementation for Young Infants with Clinical Severe Infection in Tanzania

President and Fellows of Harvard College

Status and phase: Begins enrollment this month; Phase 3

Conditions: Neonatal Infection

Treatments: Dietary Supplement: Zinc Supplements; Dietary Supplement: Placebo Supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT06102044

IRB23-0138

Details and patient eligibility

About

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.

Enrollment: 3,250 estimated patients

Sex: All

Ages: Under 59 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Prior use of zinc supplements during the current illness
• Receipt of antibiotics for >24 hours before enrollment
• Diarrhea at enrollment
• Signs suggestive of serious illness/condition that is not clinical severe infection
• Previously enrolled in the trial
• Enrolled in other research study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,250 participants in 2 patient groups, including a placebo group

Zinc Supplementation

Experimental group

Description:

14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube

Treatment:

Dietary Supplement: Zinc Supplements

Placebo

Placebo Comparator group

Description:

14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube

Treatment:

Dietary Supplement: Placebo Supplements