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

NCT ID: NCT05919472

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-07-16

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency Anemia

Keywords

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Iron deficiency Anemia Vaccine response Women of reproductive age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pre-treatment group

Participants assigned to this group will receive 200 mg oral iron on alternate days on study days 1-56.

Group Type EXPERIMENTAL

Oral iron supplementation (pre-treatment)

Intervention Type DIETARY_SUPPLEMENT

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

COVID-19 vaccine

Intervention Type BIOLOGICAL

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

MenACWY vaccine

Intervention Type BIOLOGICAL

MenACWY vaccination given on day 28 to all participants

Typhim Vi vaccine

Intervention Type BIOLOGICAL

Typhim Vi vaccination given on day 28 to all participants

Simultaneous treatment group

Participants 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.

Group Type EXPERIMENTAL

COVID-19 vaccine

Intervention Type BIOLOGICAL

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

MenACWY vaccine

Intervention Type BIOLOGICAL

MenACWY vaccination given on day 28 to all participants

Oral iron supplementation (simultaneous treatment)

Intervention Type DIETARY_SUPPLEMENT

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

Typhim Vi vaccine

Intervention Type BIOLOGICAL

Typhim Vi vaccination given on day 28 to all participants

Control group

Participants assigned to this group will receive placebo on alternate days on study days 1-56.

Group Type PLACEBO_COMPARATOR

COVID-19 vaccine

Intervention Type BIOLOGICAL

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

MenACWY vaccine

Intervention Type BIOLOGICAL

MenACWY vaccination given on day 28 to all participants

Typhim Vi vaccine

Intervention Type BIOLOGICAL

Typhim Vi vaccination given on day 28 to all participants

Interventions

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Oral iron supplementation (pre-treatment)

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

Intervention Type DIETARY_SUPPLEMENT

COVID-19 vaccine

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

Intervention Type BIOLOGICAL

MenACWY vaccine

MenACWY vaccination given on day 28 to all participants

Intervention Type BIOLOGICAL

Oral iron supplementation (simultaneous treatment)

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

Intervention Type DIETARY_SUPPLEMENT

Typhim Vi vaccine

Typhim Vi vaccination given on day 28 to all participants

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

Nicole Stoffel

OTHER

Sponsor Role lead

Responsible Party

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Nicole Stoffel

Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Simon Karanja, PhD

Role: PRINCIPAL_INVESTIGATOR

JKUAT

Locations

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Msambweni County Referral Hospital

Msambweni, , Kenya

Site Status

Countries

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Kenya

Other Identifiers

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DIVA_II

Identifier Type: -

Identifier Source: org_study_id