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Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children

NCT03596996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-08-21

No results posted yet for this study

Summary

Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation on iron status, gut microbiome profile, infectious disease frequency, and HIV disease severity in moderately anemic \[hemoglobin 9 - \<11 g/dL (6-59 mo); hemoglobin 9 - \< 11.5 g/dL (5 -12 years)\], HIV-infected Ugandan children between the ages of 6 mos and 12 years.

Conditions

Interventions

DIETARY_SUPPLEMENT

Ferrous Sulfate

Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.

DIETARY_SUPPLEMENT

Placebo

Placebo with identical appearance comparison intervention arm

Sponsors & Collaborators

Principal Investigators

  • Sarah Cusick, PhD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2020-02-10
Completion
2020-02-10

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03596996 on ClinicalTrials.gov