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

NCT04931641 | Completed DMC

• 1 other identifier: Fe-GOS-HIV
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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. 1.iron status measured by conventional iron status biomarkers,
2. 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. 3.systemic and gut inflammation, as well as gut mucosal integrity,
4. 4.gut microbiome composition, and
5. 5.adverse effects and gastrointestinal side-effects.

Conditions

Iron Deficiency; HIV

Outcome Measures

Primary Outcomes (5)

• Iron status: Serum Ferritin (ug/L) (SF)

  Change in SF concentrations over the study period of 12 weeks

  0, 6, 12 weeks

• Iron status: Soluble Transferrin Receptor (mg/L) (sTfR)

  Change in sTfR concentrations over the study period of 12 weeks

  0, 6, 12 weeks

• Iron status: Transferrin saturation (%) (Tsat)

  Change in Tsat concentrations over the study period of 12 weeks

  0, 6, 12 weeks

• Iron status: Hemoglobin (g/dL) (Hb)

  Change in Hb concentrations over the study period of 12 weeks

  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.

  0, 6, 12 weeks

Secondary Outcomes (10)

• Systemic inflammation: C-reactive protein (mg/L) (CRP)

  0, 6, 12 weeks

• Systemic inflammation: Alpha-1-acid glycoprotein (g/L) (AGP)

  0, 6, 12 weeks

• Hepcidin (nM)

  0, 6, 12 weeks

• Gut inflammation: Intestinal fatty acids binding protein (ng/ml) (IFABP)

  0 and 12 weeks

• Gut inflammation: Fecal calprotectin (µg/g)

  0 and 12 weeks

Study Arms (2)

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

Interventions

Galacto-oligosaccharides DIETARY_SUPPLEMENT

Prebiotic galacto-oligosaccharides (GOS)

Also known as: Prebiotic

50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g galacto-oligosaccharides

Maltodextrin OTHER

Maltodextrin (placebo)

50 mg oral iron as ferrous fumarate (FeFum) with 7.5 g maltodextrin

Ferrous fumarate DIETARY_SUPPLEMENT

50 mg iron as ferrous fumarate

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

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• University of Stellenbosch: collaborator

Study Sites (1)

Familiy Clinical Research Unit (FAMCRU)

Cape Town, South Africa

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Prebiotics; maltodextrin; ferrous fumarate

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Jeannine Baumgartner, PhD

  Swiss Federal Institute of Technology

  PRINCIPAL INVESTIGATOR

• Michael Zimmermann, MD

  Swiss Federal Institute of Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 18, 2021
• Study Start: August 1, 2021
• Primary Completion: October 4, 2022
• Study Completion: October 4, 2022
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)