NCT03572010

Stable Iron Isotope Method in HIV+ and HIV- Children

Completed NA Last updated 14 September 2021

What this trial tests

NA trial testing FeFum fortified maize test meal in Iron-deficiency in 180 participants. Completed in 30 June 2020.

Timeline

27 September 2018

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Swiss Federal Institute of Technology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	180
Start date	27 September 2018
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across South Africa

Drugs / interventions tested

• FeFum fortified maize test meal
• FeSO4 fortified LNS
• FeSO4 supplement
• FeSO4 fortified fruit juice

Conditions studied

• Iron-deficiency — all drugs for Iron-deficiency →

Sponsor

Swiss Federal Institute of Technology

Who can join

Adults 8 to 13, any sex, with Iron-deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to compare HIV infected children to uninfected children regarding 1) quantifying iron absorption from iron fortified maize porridge, lipid-based food supplements and oral iron supplements, and 2) quantifying the daily iron requirement.

Publications & conference data

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

1. Associations of HIV and iron status with gut microbiota composition, gut inflammation and gut integrity in South African school-age children: a two-way factorial case-control study.
   Goosen C, Proost S, Baumgartner J, Mallick K, et al · · 2023 · cited 14× · PMID 36992541 · DOI 10.1111/jhn.13171
2. The effect of oral iron supplementation on the gut microbiota, gut inflammation, and iron status in iron-depleted South African school-age children with virally suppressed HIV and without HIV.
   Goosen C, Proost S, Tito RY, Baumgartner J, et al · · 2022 · cited 4× · PMID 34997267 · DOI 10.1007/s00394-021-02793-9
3. Examining Associations of HIV and Iron Status with Nutritional and Inflammatory Status, Anemia, and Dietary Intake in South African Schoolchildren.
   Goosen C, Baumgartner J, Mikulic N, Barnabas SL, et al · · 2021 · cited 4× · PMID 33809705 · DOI 10.3390/nu13030962
4. Iron absorption and loss, and efficacy of iron supplementation with and without prebiotics in children with virally suppressed HIV: three prospective studies in South Africa.
   Baumgartner J, Blaauw R, Mikulic N, Goosen C, et al · · 2025 · cited 1× · PMID 41233303 · DOI 10.1038/s41467-025-64998-4