Iron Deficiency AnemiaDIVA_IINCT06116669
Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
A study testing Iron supplementation, MenACWY vaccine and COVID-19 vaccine in people with Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 1 site in Kenya.
Trial summary
Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Iron supplementation, MenACWY vaccine and COVID-19 vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteKenya
- Study dates
- 1 Nov 2023to 31 Dec 2024
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give informed consent for participation in the trial
- Female aged 18-49 years
- Moderate anemia (Hb <110 g/L, but not severely anemic with Hb <80 g/L)
- Iron deficient (ZnPP >40 mmol/mol haem)
- Anticipated residence in the study area for the study duration
Who cannot join
- Major chronic infecious disease (e.g., HIV infection);
- Major chronic non-infecious disease (e.g., Type 2 diabetes, cancer);
- Chronic medications;
- Use of iron-containing mineral and vitamin supplementation 2 weeks prior to study start;
- COVID-19 vaccine or confirmed COVID-19 infection within the past 2 years
- MenACWY vaccine in the past
Show all 9Show fewer
- Typhim Vi vaccine in the past
- Pregnant (confirmed by rapid test during screening)
- Malaria (confirmed by rapid test) à study start will be postponed
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
Jomo Kenyatta University Of Agriculture And Technology
Nairobi, 00200
Simon Karanja, PhD, +254726424669, skaranja@jkuat.ac.ke
About this study
Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation.
The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination).
We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson \& Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Iron supplementation, MenACWY vaccine, COVID-19 vaccine, Placebo, Typhim Vi vaccine
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron supplementationDietary supplement
Iron supplements as 100 mg oral iron as FeSO4 given daily
MenACWY vaccineBiological
MenACWY vaccination given on day 28 to all participants
COVID-19 vaccineBiological
Johnson \& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants
PlaceboOther
matching placebo capsules given daily
Typhim Vi vaccineBiological
Typhim Vi vaccination given on day 28 to all participants
| Study group | Role | What they receive |
|---|---|---|
| Pre-treatment group | Experimental | Participants assigned to this group will receive 100 mg oral iron daily on study days 1-56. Receives: Dietary Supplement: Iron supplementation; Biological: MenACWY vaccine; Biological: COVID-19 vaccine; Biological: Typhim Vi vaccine |
| Simultaneous treatment group | Experimental | Participants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56. Receives: Dietary Supplement: Iron supplementation; Biological: MenACWY vaccine; Biological: COVID-19 vaccine; Other: Placebo; Biological: Typhim Vi vaccine |
| Control group | Placebo comparator | Participants assigned to this group will receive placebo daily on study days 1-56. Receives: Dietary Supplement: Iron supplementation; Biological: MenACWY vaccine; Biological: COVID-19 vaccine; Other: Placebo; Biological: Typhim Vi vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
JJ COVID-19 vaccine response
Anti-spike (S1) IgG and anti-receptor-binding domain (RBD) IgG against SARS-COV-2
Measured: Day 56
MenACWY vaccine response
Measurement of antibody response against serogroups A, C, W, and Y.
Measured: Day 56
Typhoid vaccine response
Measurement of antibody response against Typhoid
Measured: Day 56
Secondary outcomes (34)
Hemoglobin
iron status
Measured: Day 1
Hemoglobin
iron status
Measured: Day 28
Hemoglobin
iron status
Measured: Day 56
Serum ferritin
iron status
Measured: Day 1
Serum ferritin
iron status
Measured: Day 28
Serum ferritin
iron status
Measured: Day 56
soluble transferrin receptor
iron status
Measured: Day 1
soluble transferrin receptor
iron status
Measured: Day 28
soluble transferrin receptor
iron status
Measured: Day 56
Plasma iron
iron status
Measured: Day 1
Plasma iron
iron status
Measured: Day 28
Plasma iron
iron status
Measured: Day 56
Total iron binding capacity
iron status
Measured: Day 1
Total iron binding capacity
iron status
Measured: Day 28
Total iron binding capacity
iron status
Measured: Day 56
Transferrin saturation
iron status
Measured: Day 1
Transferrin saturation
iron status
Measured: Day 28
Transferrin saturation
iron status
Measured: Day 56
C- reactive protein
inflammation status
Measured: Day 1
C- reactive protein
inflammation status
Measured: Day 28
C- reactive protein
inflammation status
Measured: Day 56
alpha- 1- glycoprotein
inflammation status
Measured: Day 1
alpha- 1- glycoprotein
inflammation status
Measured: Day 28
alpha- 1- glycoprotein
inflammation status
Measured: Day 56
Retinol binding protein
Vitamin A status
Measured: Day 1
Retinol binding protein
Vitamin A status
Measured: Day 28
Retinol binding protein
Vitamin A status
Measured: Day 56
Plasma zinc
Zinc status
Measured: Day 1
COVID-19 specific T cell response
QuantiFERON SARS-CoV-2 whole blood assay - detection of IFN-gamma
Measured: Day 28
COVID-19 specific T cell response
QuantiFERON SARS-CoV-2 whole blood assay - detection of IFN-gamma
Measured: Day 56
COVID-19 specific T cell response
ELISpot assay on isolated peripheral blood mononuclear cells
Measured: Day 28
COVID-19 specific T cell response
ELISpot assay on isolated peripheral blood mononuclear cells
Measured: Day 56
Typhim Vi specific B-cell response
ELISpot assay on isolated peripheral blood mononuclear cells
Measured: Day 28
Typhim Vi specific B-cell response
ELISpot assay on isolated peripheral blood mononuclear cells
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology, University of Oxford
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116669
- Sponsor's protocol ID
- DIVA_II
- Acronym
- DIVA_II
- Status last verified
- Jan 2024
- First submitted
- 30 Oct 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
- ClinicalTrials.gov ID
- NCT06116669
- Acronym / sponsor ID
- DIVA_II / DIVA_II
- Conditions
- Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology, University of Oxford
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Nov 2023 (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 deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation.
The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination).
We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson \& Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-treatment group | Experimental | Dietary Supplement: Iron supplementation, Biological: MenACWY vaccine, Biological: COVID-19 vaccine, Biological: Typhim Vi vaccineParticipants assigned to this group will receive 100 mg oral iron daily on study days 1-56. |
| Simultaneous treatment group | Experimental | Dietary Supplement: Iron supplementation, Biological: MenACWY vaccine, Biological: COVID-19 vaccine, Other: Placebo, Biological: Typhim Vi vaccineParticipants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56. |
| Control group | Placebo comparator | Dietary Supplement: Iron supplementation, Biological: MenACWY vaccine, Biological: COVID-19 vaccine, Other: Placebo, Biological: Typhim Vi vaccineParticipants assigned to this group will receive placebo daily on study days 1-56. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to give informed consent for participation in the trial
- Female aged 18-49 years
- Moderate anemia (Hb <110 g/L, but not severely anemic with Hb <80 g/L)
- Iron deficient (ZnPP >40 mmol/mol haem)
- Anticipated residence in the study area for the study duration
Key exclusion criteria (9 listed)
- Major chronic infecious disease (e.g., HIV infection);
- Major chronic non-infecious disease (e.g., Type 2 diabetes, cancer);
- Chronic medications;
- Use of iron-containing mineral and vitamin supplementation 2 weeks prior to study start;
- COVID-19 vaccine or confirmed COVID-19 infection within the past 2 years
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 |
|---|---|---|
| Iron supplementationIron supplements as 100 mg oral iron as FeSO4 given daily | Dietary supplement | Control group, Pre-treatment group, Simultaneous treatment group |
| MenACWY vaccineMenACWY vaccination given on day 28 to all participants | Biological | Control group, Pre-treatment group, Simultaneous treatment group |
| COVID-19 vaccineJohnson \& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants | Biological | Control group, Pre-treatment group, Simultaneous treatment group |
| Placebomatching placebo capsules given daily | Other | Control group, Simultaneous treatment group |
| Typhim Vi vaccineTyphim Vi vaccination given on day 28 to all participants | Biological | Control group, Pre-treatment group, Simultaneous treatment group |
Primary outcome
JJ COVID-19 vaccine response
Time frame: Day 56
Anti-spike (S1) IgG and anti-receptor-binding domain (RBD) IgG against SARS-COV-2
MenACWY vaccine response
Time frame: Day 56
Measurement of antibody response against serogroups A, C, W, and Y.
Typhoid vaccine response
Time frame: Day 56
Measurement of antibody response against Typhoid
34 secondary outcomes
Hemoglobin
Time frame: Day 1
Hemoglobin
Time frame: Day 28
Hemoglobin
Time frame: Day 56
Serum ferritin
Time frame: Day 1
Serum ferritin
Time frame: Day 28
Serum ferritin
Time frame: Day 56
soluble transferrin receptor
Time frame: Day 1
soluble transferrin receptor
Time frame: Day 28
soluble transferrin receptor
Time frame: Day 56
Plasma iron
Time frame: Day 1
Plasma iron
Time frame: Day 28
Plasma iron
Time frame: Day 56
Total iron binding capacity
Time frame: Day 1
Total iron binding capacity
Time frame: Day 28
Total iron binding capacity
Time frame: Day 56
Transferrin saturation
Time frame: Day 1
Transferrin saturation
Time frame: Day 28
Transferrin saturation
Time frame: Day 56
C- reactive protein
Time frame: Day 1
C- reactive protein
Time frame: Day 28
C- reactive protein
Time frame: Day 56
alpha- 1- glycoprotein
Time frame: Day 1
alpha- 1- glycoprotein
Time frame: Day 28
alpha- 1- glycoprotein
Time frame: Day 56
Retinol binding protein
Time frame: Day 1
Retinol binding protein
Time frame: Day 28
Retinol binding protein
Time frame: Day 56
Plasma zinc
Time frame: Day 1
COVID-19 specific T cell response
Time frame: Day 28
COVID-19 specific T cell response
Time frame: Day 56
COVID-19 specific T cell response
Time frame: Day 28
COVID-19 specific T cell response
Time frame: Day 56
Typhim Vi specific B-cell response
Time frame: Day 28
Typhim Vi specific B-cell response
Time frame: Day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron supplementation, MenACWY vaccine and COVID-19 vaccine in people with Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 1 site in Kenya.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Jan 2024. 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 Kenya. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Pironaci, MSc (+41 44 632 93 29, giulia.pironaci@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JJ COVID-19 vaccine response (time frame: Day 56). 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?
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 24 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.