MedTrace Logo

Potential of Prebiotic Galacto-oligosaccharides in Improving Efficacy and Safety of Oral Iron Supplementation in HIV-infected Children

NCT04931641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-03-07

No results posted yet for this study

Summary

The objectives of this randomized controlled trial in virally suppressed HIV-positive children with anemia and/or depleted iron stores are to determine the effect of prebiotic galacto-oligosaccharides (GOS) as adjunct treatment to 12 weeks of oral iron supplementation on:

1. iron status measured by conventional iron status biomarkers,
2. fractional absorption of iron (fraction of total body iron per day, measured as Kabs, the slope of 57Fe isotopic dilution) and mean total amount of iron absorbed each day (mg Fe/day, calculated as Kabs x mean total body iron),
3. systemic and gut inflammation, as well as gut mucosal integrity,
4. gut microbiome composition, and
5. adverse effects and gastrointestinal side-effects.

Conditions

Interventions

DIETARY_SUPPLEMENT

Galacto-oligosaccharides

Prebiotic galacto-oligosaccharides (GOS)

OTHER

Maltodextrin

Maltodextrin (placebo)

DIETARY_SUPPLEMENT

Ferrous fumarate

50 mg iron as ferrous fumarate

Sponsors & Collaborators

  • University of Stellenbosch

    collaborator OTHER

  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Jeannine Baumgartner, PhD · Swiss Federal Institute of Technology

  • Michael Zimmermann, MD · Swiss Federal Institute of Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-10-04
Completion
2022-10-04

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT04931641 on ClinicalTrials.gov