Iron DeficiencyNCT04931641

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

A study testing Galacto-oligosaccharides, Maltodextrin and Ferrous fumarate in people with Iron Deficiency and HIV, run by Swiss Federal Institute of Technology at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 10 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Iron Deficiency, HIV
What is being tested?: Galacto-oligosaccharides, Maltodextrin and Ferrous fumarate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 1 siteSouth Africa
Study dates: 1 Aug 2021to 4 Oct 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 15 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Age 10-15 years at baseline;
Mild to moderate micro- and normocytic anaemia defined as Hb ≥8.0 and <11.5 / 12 g/dL (children 10-11 / 12-15 years) plus mean corpuscular volume ≤91.5 fL and/or iron deficiency defined as ferritin <30 µg/L or sTfR >8.3 mg/L;
Body-Mass-Index-for-age Z-scores (BAZ) -3 to 2 SD of reference population;
HIV criteria: HIV RNA viral load <50 copies/mL (measured as part of routine care);
Willingness of caregiver to participate in the study;
Caregiver speaks English, Afrikaans or isiXhosa;
The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy) plus assent needs to be obtained from the child;
Residence in the study area for the period of the study.

Who cannot join

Child received iron supplements or antibiotic treatment 3 months prior to study start;
Acute illness or other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol;
Participants taking part in other studies involving medical or physical interventions.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Familiy Clinical Research Unit (FAMCRU)
Cape Town

Other trials in South Africa

About this study

Official title: Improving Efficacy and Safety of Oral Iron Supplementation in HIV-infected Children by Providing Prebiotic Galacto-oligosaccharides As Adjunct Treatment: a Randomized Controlled Trial

iron status measured by conventional iron status biomarkers,
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),
systemic and gut inflammation, as well as gut mucosal integrity,
gut microbiome composition, and
adverse effects and gastrointestinal side-effects.

Read the detailed description

Iron deficiency anemia (IDA) in childhood can impair growth and cognition, as well as reduce school performance. Furthermore, anemia frequently complicates pediatric HIV infection and predicts disease progression and mortality. However, there is no international consensus on the treatment of ID and IDA in HIV-infected children, because of concerns around the efficacy and safety of oral iron supplements. Recent studies have suggested that oral iron supplements may increase gut inflammation in African children. This could be particularly detrimental in HIV-infected children, who may have gut immune activation, enteropathy and adverse shifts in the gut microbiome.

Previous stable iron isotope studies from the ETH Laboratory of Human Nutrition showed that the consumption of prebiotic galacto-oligosaccharides (GOS) together with supplemental doses of iron can increase iron absorption. In Kenyan infants, we further showed that the addition of GOS to an iron-containing micronutrient powder mitigated the adverse effects of iron on the gut microbiome.

Thus, we hypothesize that providing GOS as adjunct treatment to oral iron supplementation will improve efficacy (iron absorption and iron status), reduce systemic and gut inflammation, improve mucosal integrity, and mitigated iron-induced alterations in the gut microbiome, adverse events and gastrointestinal side-effects in virally suppressed HIV-infected children.

Conditions: Iron Deficiency, HIV
Being tested: Galacto-oligosaccharides, Maltodextrin, Ferrous fumarate
Medical subject headings: Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Galacto-oligosaccharidesDietary supplement
Also called Prebiotic
Prebiotic galacto-oligosaccharides (GOS)
MaltodextrinOther
Maltodextrin (placebo)
Ferrous fumarateDietary supplement
50 mg iron as ferrous fumarate

Study groups in NCT04931641
Study group	Role	What they receive
50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g galacto-oligosaccharides	Experimental	Not described Receives: Dietary Supplement: Galacto-oligosaccharides; Dietary Supplement: Ferrous fumarate
50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g maltodextrin	Placebo comparator	Not described Receives: Other: Maltodextrin; Dietary Supplement: Ferrous fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

Iron status: Serum Ferritin (ug/L) (SF)
Change in SF concentrations over the study period of 12 weeks
Measured: 0, 6, 12 weeks
Iron status: Soluble Transferrin Receptor (mg/L) (sTfR)
Change in sTfR concentrations over the study period of 12 weeks
Measured: 0, 6, 12 weeks
Iron status: Transferrin saturation (%) (Tsat)
Change in Tsat concentrations over the study period of 12 weeks
Measured: 0, 6, 12 weeks
Iron status: Hemoglobin (g/dL) (Hb)
Change in Hb concentrations over the study period of 12 weeks
Measured: 0, 6, 12 weeks
Fractional iron absorption
Fractional absorption of iron will be determined by measuring Kabs, the slope of 57Fe isotopic dilution over the study period. From this value, mean total amount of iron absorbed each day (mg Fe/day, calculated as Kabs x mean total body iron) can be estimated.
Measured: 0, 6, 12 weeks

Secondary outcomes (10)

Systemic inflammation: C-reactive protein (mg/L) (CRP)
Change in CRP concentrations over the study period of 12 weeks
Measured: 0, 6, 12 weeks
Systemic inflammation: Alpha-1-acid glycoprotein (g/L) (AGP)
Change in AGP concentrations over the study period of 12 weeks
Measured: 0, 6, 12 weeks
Hepcidin (nM)
Change in hepcidin concentrations over the study period of 12 weeks
Measured: 0, 6, 12 weeks
Gut inflammation: Intestinal fatty acids binding protein (ng/ml) (IFABP)
Change in IFABP concentrations from baseline (0 weeks) to endpoint (12 weeks)
Measured: 0 and 12 weeks
Gut inflammation: Fecal calprotectin (µg/g)
Change in fecal calprotectin concentrations from baseline (0 weeks) to endpoint (12 weeks)
Measured: 0 and 12 weeks
Gut inflammation: Myeloperoxidase (µg /mL) (MPO)
Change in MPO concentrations from baseline (0 weeks) to endpoint (12 weeks)
Measured: 0 and 12 weeks
Gut microbiome composition
Change in gut microbiome composition from baseline (0 weeks) to endpoint (12 weeks)
Measured: 0 and 12 weeks
Fecal pH
Change in fecal pH from baseline (0 weeks) to endpoint (12 weeks)
Measured: 0 and 12 weeks
HIV viral load (copies/ml)
Change in HIV viral load from baseline (0 weeks) to endpoint (12 weeks)
Measured: 0 and 12 weeks
Gastrointestinal and respiratory symptoms
Self-reported gastrointestinal and respiratory symptoms assessed using a symptoms diary over the study period of 12 weeks
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20214 Oct 2022

First posted18 Jun 2021
Study start1 Aug 2021
Primary completion4 Oct 2022
Study completion4 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Iron DeficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Parallel groups
Model description: Randomized controlled trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04931641
Sponsor's protocol ID: Fe-GOS-HIV
Status last verified: Feb 2025
First submitted: 15 Jun 2021
Last updated: 7 Mar 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency

All Iron Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Efficacy and Safety of Oral Iron Supplementation in HIV-infected Children by Providing Prebiotic Galacto-oligosaccharides As Adjunct Treatment: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04931641
Acronym / sponsor ID: Fe-GOS-HIV
Conditions: Iron Deficiency, HIV
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Swiss Federal Institute of TechnologyUniversity, hospital or other
Collaborators: University of Stellenbosch
Study start: 1 Aug 2021 (actual)
Primary completion: 4 Oct 2022 (actual)
Study completion: 4 Oct 2022 (actual)
First posted: 18 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

iron status measured by conventional iron status biomarkers,
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),
systemic and gut inflammation, as well as gut mucosal integrity,
gut microbiome composition, and
adverse effects and gastrointestinal side-effects.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized controlled trial

Arm	Type	Receives
50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g galacto-oligosaccharides	Experimental	Dietary Supplement: Galacto-oligosaccharides, Dietary Supplement: Ferrous fumarate
50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g maltodextrin	Placebo comparator	Other: Maltodextrin, Dietary Supplement: Ferrous fumarate

Who may qualify

Ages: 10 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Age 10-15 years at baseline;
Mild to moderate micro- and normocytic anaemia defined as Hb ≥8.0 and <11.5 / 12 g/dL (children 10-11 / 12-15 years) plus mean corpuscular volume ≤91.5 fL and/or iron deficiency defined as ferritin <30 µg/L or sTfR >8.3 mg/L;
Body-Mass-Index-for-age Z-scores (BAZ) -3 to 2 SD of reference population;
HIV criteria: HIV RNA viral load <50 copies/mL (measured as part of routine care);
Willingness of caregiver to participate in the study;

Key exclusion criteria (3 listed)

Child received iron supplements or antibiotic treatment 3 months prior to study start;
Acute illness or other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol;
Participants taking part in other studies involving medical or physical interventions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Galacto-oligosaccharidesAlso: PrebioticPrebiotic galacto-oligosaccharides (GOS)	Dietary supplement	50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g galacto-oligosaccharides
MaltodextrinMaltodextrin (placebo)	Other	50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g maltodextrin
Ferrous fumarate50 mg iron as ferrous fumarate	Dietary supplement	50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g galacto-oligosaccharides, 50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g maltodextrin

Primary outcome

Iron status: Serum Ferritin (ug/L) (SF)
Time frame: 0, 6, 12 weeks
Change in SF concentrations over the study period of 12 weeks
Iron status: Soluble Transferrin Receptor (mg/L) (sTfR)
Time frame: 0, 6, 12 weeks
Change in sTfR concentrations over the study period of 12 weeks
Iron status: Transferrin saturation (%) (Tsat)
Time frame: 0, 6, 12 weeks
Change in Tsat concentrations over the study period of 12 weeks
Iron status: Hemoglobin (g/dL) (Hb)
Time frame: 0, 6, 12 weeks
Change in Hb concentrations over the study period of 12 weeks
Fractional iron absorption
Time frame: 0, 6, 12 weeks
Fractional absorption of iron will be determined by measuring Kabs, the slope of 57Fe isotopic dilution over the study period. From this value, mean total amount of iron absorbed each day (mg Fe/day, calculated as Kabs x mean total body iron) can be estimated.

10 secondary outcomes

Systemic inflammation: C-reactive protein (mg/L) (CRP)
Time frame: 0, 6, 12 weeks
Systemic inflammation: Alpha-1-acid glycoprotein (g/L) (AGP)
Time frame: 0, 6, 12 weeks
Hepcidin (nM)
Time frame: 0, 6, 12 weeks
Gut inflammation: Intestinal fatty acids binding protein (ng/ml) (IFABP)
Time frame: 0 and 12 weeks
Gut inflammation: Fecal calprotectin (µg/g)
Time frame: 0 and 12 weeks
Gut inflammation: Myeloperoxidase (µg /mL) (MPO)
Time frame: 0 and 12 weeks
Gut microbiome composition
Time frame: 0 and 12 weeks
Fecal pH
Time frame: 0 and 12 weeks
HIV viral load (copies/ml)
Time frame: 0 and 12 weeks
Gastrointestinal and respiratory symptoms
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Iron Deficiency

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeannine Baumgartner, PhD principal investigator

Swiss Federal Institute of Technology

Michael Zimmermann, MD study chair

Swiss Federal Institute of Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Galacto-oligosaccharides, Maltodextrin and Ferrous fumarate in people with Iron Deficiency and HIV, run by Swiss Federal Institute of Technology at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Iron status: Serum Ferritin (ug/L) (SF) (time frame: 0, 6, 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04931641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.