AnemiaNCT03596996
Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
A study testing Ferrous Sulfate in people with Anemia and Iron-deficiency, run by University of Minnesota at 1 site in Uganda.
Trial summary
Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation on iron status, gut microbiome profile, infectious disease frequency, and HIV disease severity in moderately anemic [hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL (5 -12 years)], HIV-infected Ugandan children… Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Anemia, Iron-deficiency, Iron Deficiency Anemia
- What is being tested?
- Ferrous Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUganda
- Study dates
- 19 Apr 2018to 10 Feb 2020
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of HIV (based JCRC clinic records);
- On Highly Active Antiretroviral Treatment (HAART) for ≥ 6 months
- Age 6 months - 12 years at the time of screening
- Hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL (5 -12 years)by CBC at time of screening
Who cannot join
- Acute illness or current opportunistic infection
- Temperature >= 38.0°C at the time of screening
- Known sickle cell disease
- Acute malnutrition (bilateral pitting edema or extreme wasting)
- Any chronic illness requiring regular medical attention
- Residence > 50 km from JCRC hospital
- Non-English or Luganda speaking
- Currently taking iron supplements
Trial locations and contacts
1 site in 1 country.
About this study
Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation on iron status, gut microbiome profile, infectious disease frequency, and HIV disease severity in moderately anemic [hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL (5 -12 years)], HIV-infected Ugandan children between the ages of 6 mos and 12 years.
- Conditions
- Anemia, Iron-deficiency, Iron Deficiency Anemia, Hiv
- Being tested
- Ferrous Sulfate, Placebo
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous SulfateDietary supplement
Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.
PlaceboDietary supplement
Placebo with identical appearance comparison intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Ferrous Sulfate | Experimental | Children 6 to 23 months of age will receive a tablet that contains the equivalent of 12.5 mg of elemental iron. Children over 24 months will receive a tablet that contains the equivalent of 30 mg of elemental iron. Receives: Dietary Supplement: Ferrous Sulfate |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Measurement of hemoglobin
Measured: 3 months
Anemia
Prevalence of anemia
Measured: 3 months
Iron status
Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma
Measured: 3 months
Secondary outcomes (4)
Sick Child Visits
Number of acute illnesses leading to visit to healthcare provider
Measured: 3 months
Dietary iron absorption
Percentage of 57Fe from oral dose that is incorporated into hemoglobin
Measured: 2 weeks
HIV virologic control
HIV viral load
Measured: 3 month
HIV related immunosuppression
CD4 count
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start19 Apr 2018
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Joint Clinical Research Center
- Responsible party
- Sponsor
- Investigators
- Sarah Cusick, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596996
- Sponsor's protocol ID
- 1608M92324
- Status last verified
- Aug 2020
- First submitted
- 5 Jun 2018
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available on request.
Publications
Frosch AEP, Musiime V, Staley C, Conroy AL, Rutebarika D, Ategeka G, Cusick SE. Safety and efficacy of iron supplementation with 3 months of daily ferrous sulphate in children living with HIV and mild-to-moderate anaemia in Uganda: a double-blind, randomised, placebo-controlled trial. Lancet HIV. 2024 Nov;11(11):e727-e735. doi: 10.1016/S2352-3018(24)00238-8. Epub 2024 Oct 11.
PubMed 39401504
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
- ClinicalTrials.gov ID
- NCT03596996
- Acronym / sponsor ID
- 1608M92324
- Conditions
- Anemia, Iron-deficiency, Iron Deficiency Anemia, Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Joint Clinical Research Center
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 24 Jul 2018 (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.
Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation on iron status, gut microbiome profile, infectious disease frequency, and HIV disease severity in moderately anemic [hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL (5 -12 years)], HIV-infected Ugandan children between the ages of 6 mos and 12 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous Sulfate | Experimental | Dietary Supplement: Ferrous SulfateChildren 6 to 23 months of age will receive a tablet that contains the equivalent of 12.5 mg of elemental iron. Children over 24 months will receive a tablet that contains the equivalent of 30 mg of elemental iron. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Confirmed diagnosis of HIV (based JCRC clinic records);
- On Highly Active Antiretroviral Treatment (HAART) for ≥ 6 months
- Age 6 months - 12 years at the time of screening
- Hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL (5 -12 years)by CBC at time of screening
Key exclusion criteria (8 listed)
- Acute illness or current opportunistic infection
- Temperature >= 38.0°C at the time of screening
- Known sickle cell disease
- Acute malnutrition (bilateral pitting edema or extreme wasting)
- Any chronic illness requiring regular medical attention
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 |
|---|---|---|
| Ferrous SulfateFerrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia. | Dietary supplement | Ferrous Sulfate |
| PlaceboPlacebo with identical appearance comparison intervention arm | Dietary supplement | Placebo |
Primary outcome
Hemoglobin
Time frame: 3 months
Measurement of hemoglobin
Anemia
Time frame: 3 months
Prevalence of anemia
Iron status
Time frame: 3 months
Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma
4 secondary outcomes
Sick Child Visits
Time frame: 3 months
Dietary iron absorption
Time frame: 2 weeks
HIV virologic control
Time frame: 3 month
HIV related immunosuppression
Time frame: 3 months
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 21 Aug 2020.
- Derived from this study: PubMed 39401504Frosch AEP, Musiime V, Staley C, Conroy AL, Rutebarika D, Ategeka G, Cusick SE. Safety and efficacy of iron supplementation with 3 months of daily ferrous sulphate in children living with HIV and mild-to-moderate anaemia in Uganda: a double-blind, randomised, placebo-controlled trial. Lancet HIV. 2024 Nov;11(11):e727-e735. doi: 10.1016/S2352-3018(24)00238-8. Epub 2024 Oct 11.
- Individual participant dataSharing planned: Yes. IPD will be available on request.
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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.
Sarah Cusick, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulfate in people with Anemia and Iron-deficiency, run by University of Minnesota at 1 site in Uganda.
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 4 inclusion and 8 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 21 Aug 2020. 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 Uganda. 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?
Hemoglobin (time frame: 3 months). The study lists 3 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 NCT03596996, which also lists 1 linked publication.
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 21 Aug 2020.