Potential of Prebiotic Galacto-oligosaccharides in Improving Efficacy and Safety of Oral Iron Sup… (NCT04931641) | Clinical Trial Compass
CompletedNot Applicable
Potential of Prebiotic Galacto-oligosaccharides in Improving Efficacy and Safety of Oral Iron Supplementation in HIV-infected Children
South Africa86 participantsStarted 2021-08-01
Plain-language 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.
Who can participate
Age range
10 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Iron status: Serum Ferritin (ug/L) (SF)
Timeframe: 0, 6, 12 weeks
2
Iron status: Soluble Transferrin Receptor (mg/L) (sTfR)