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Iron Deficiency AnemiaNCT05919472

Effects of Oral Iron Supplementation on Vaccine Response in Iron Deficient Kenyan Women

A study testing Oral iron supplementation (pre-treatment), COVID-19 vaccine and MenACWY vaccine in people with Iron Deficiency Anemia, run by Nicole Stoffel at 1 site in Kenya.

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

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?
Oral iron supplementation (pre-treatment), COVID-19 vaccine and MenACWY vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteKenya
Study dates
1 Jul 2023to 16 Jul 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 infectious disease (e.g., HIV infection);
  • Major chronic non-infectious 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
  • Typhoid vaccine in the past
  • Pregnant (confirmed by rapid test during screening) or lactating.
  • Malaria (confirmed by rapid test) à study start will be postponed

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Msambweni County Referral Hospital

    Msambweni, 80404

Other trials in Kenya

About this study

Official title: Effects of Oral Iron Supplementation Before vs. at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women

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.

Being tested
Oral iron supplementation (pre-treatment), COVID-19 vaccine, MenACWY vaccine, Oral iron supplementation (simultaneous treatment), Typhim Vi vaccine
Keywords
Iron deficiency, Anemia, Vaccine response, Women of reproductive age
Medical subject headings
Anemia, Iron-Deficiency, Iron Deficiencies, Anemia

What participants receive

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

  • Oral iron supplementation (pre-treatment)Dietary supplement

    Iron supplements as 200 mg oral iron as FeSO4 given on alternate day on days 1-56

  • COVID-19 vaccineBiological

    Johnson \& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants

  • MenACWY vaccineBiological

    MenACWY vaccination given on day 28 to all participants

  • Oral iron supplementation (simultaneous treatment)Dietary supplement

    Iron supplements as 200 mg oral iron as FeSO4 given on alternate day on days 28-56

  • Typhim Vi vaccineBiological

    Typhim Vi vaccination given on day 28 to all participants

Study groups in NCT05919472
Study groupRoleWhat they receive
Pre-treatment groupExperimentalParticipants assigned to this group will receive 200 mg oral iron on alternate days on study days 1-56.
Receives: Dietary Supplement: Oral iron supplementation (pre-treatment); Biological: COVID-19 vaccine; Biological: MenACWY vaccine; Biological: Typhim Vi vaccine
Simultaneous treatment groupExperimentalParticipants assigned to this group will receive placebo on alternate days on study days 1-28 and 200 mg oral iron on alternate days on study days 29-56.
Receives: Biological: COVID-19 vaccine; Biological: MenACWY vaccine; Dietary Supplement: Oral iron supplementation (simultaneous treatment); Biological: Typhim Vi vaccine
Control groupPlacebo comparatorParticipants assigned to this group will receive placebo on alternate days on study days 1-56.
Receives: Biological: COVID-19 vaccine; Biological: MenACWY vaccine; Biological: Typhim Vi vaccine

What is being measured

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

  1. anti-spike (S1) immunoglobulin (IgG) and anti-receptor-binding domain (RBD) IgG concentrations against severe acute respiratory syndrome (SARS)-Coronavirus (COV)-2 [iU/ml]

    Measured: Day 56

  2. IgG concentration against meningococcal serogroups A, C, W, and Y (anti-MenACWY IgG) [iU/ml]

    Measured: Day 56

  3. IgG concentration against Typhoid [iU/ml]

    Measured: Day 56

Secondary outcomes (33)

  1. Hemoglobin concentration (g/L) at baseline

    Measured: Day 1

  2. Hemoglobin concentration (g/L) at time of vaccination

    Measured: Day 28

  3. Hemoglobin concentration (g/L) at study end

    Measured: Days 56

  4. Zinc protoporphyrin concentration (µmol/mol heme) at baseline

    Measured: Day 1

  5. Zinc protoporphyrin concentration (µmol/mol heme) at time of vaccination

    Measured: Day 28

  6. Zinc protoporphyrin concentration (µmol/mol heme) at study end

    Measured: Day 56

  7. Plasma iron concentration (µg/mL) at baseline

    Measured: Day 1

  8. Plasma iron concentration (µg/mL) at time of vaccination

    Measured: Day 28

  9. Plasma iron concentration (µg/mL) at study end

    Measured: Day 56

  10. Total iron binding capacity at baseline

    Measured: Day 1

  11. Total iron binding capacity at time of vaccination

    Measured: Day 28

  12. Total iron binding capacity at study end

    Measured: Day 56

  13. Transferrin saturation (%) at baseline

    Measured: Day 1

  14. Transferrin saturation (%) at time of vaccination

    Measured: Day 28

  15. Transferrin saturation (%) at study end

    Measured: Day 56

  16. Plasma ferritin concentration (µg/L) at baseline

    Measured: Day 1

  17. Plasma ferritin concentration (µg/L) at time of vaccination

    Measured: Day 28

  18. Plasma ferritin concentration (µg/L) at study end

    Measured: Day 56

  19. Soluble transferrin receptor concentration (mg/L) at baseline

    Measured: Day 1

  20. Soluble transferrin receptor concentration (mg/L) at time of vaccination

    Measured: Day 28

  21. Soluble transferrin receptor concentration (mg/L) at study end

    Measured: Day 56

  22. C-reactive protein concentration (mg/L) at baseline

    Measured: Day 1

  23. C-reactive protein concentration (mg/L) at time of vaccination

    Measured: Day 28

  24. C-reactive protein concentration (mg/L) at study end

    Measured: Day 56

  25. Retinol binding protein concentration (µmol/L) at baseline

    Measured: Day 1

  26. Retinol binding protein concentration (µmol/L) at time of vaccination

    Measured: Day 28

  27. Retinol binding protein concentration (µmol/L) at study end

    Measured: Day 56

  28. Alpha-glycoprotein (AGP) concentration at baseline

    Measured: Day 1

  29. Alpha-glycoprotein concentration (g/L) at time of vaccination

    Measured: Day 28

  30. Alpha-glycoprotein concentration (g/L) at study end

    Measured: Day 56

  31. T-cell response assessed with an enzyme-linked immunosorbent assay (ELISA) detecting IFN-gamma produced by CD4+ and CD8+ T cell responses to SARS-CoV-2 peptides at study end

    Measured: Day 56

  32. COVID-19 specific T cell response measured in peripheral blood mononuclear cells by ELISpot assay quantifying specific cytokines' concentration.

    Measured: Day 56

  33. Typhim Vi specific B-cell response measured in peripheral blood mononuclear cells by ELISpot assay quantifying antibodies' and memory B cell concentration.

    Measured: Day 56

Timeline

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

  1. First posted26 Jun 2023
  2. Study start1 Jul 2023
  3. Primary completion16 Jul 2024
  4. Study completion16 Jul 2024

Resources

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
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05919472
Sponsor's protocol ID
DIVA_II
Status last verified
Dec 2025
First submitted
7 Jun 2023
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oral iron supplementation (pre-treatment), COVID-19 vaccine and MenACWY vaccine in people with Iron Deficiency Anemia, run by Nicole Stoffel 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 4 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: finished, as of the sponsor's last update on 26 Dec 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 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?

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?

anti-spike (S1) immunoglobulin (IgG) and anti-receptor-binding domain (RBD) IgG concentrations against severe acute respiratory syndrome (SARS)-Coronavirus (COV)-2 [iU/ml] (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?

On the ClinicalTrials.gov record for NCT05919472.

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 26 Dec 2025.

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