An interventional study of Iron syrup and Multivitamin syrup in Iron Deficiencies, sponsored by Nicole Stoffel. Recruiting at 1 site in Kenya. Open to participants aged 6 Months to 6 Months. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Nicole Stoffel · Not applicable, Interventional, and Other
Malaria and iron deficiency cause a significant burden of disease in Africa. Iron deficiency (ID) might affect immune responses to vaccination.
In this double-blind randomized controlled trial, we aim to assess: (1) whether ID impairs R21/Matrix-M, Typhim VI and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.
386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.
This study's planned enrollment of 324 is above the median of 99 across 301 interventional studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →Nicole Stoffel is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 5, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
daily multivitamin + daily iron syrup from age 6 to 10 months
Dietary Supplement: Iron syrup · Dietary Supplement: Multivitamin syrup · Biological: R21-Matrix/M Vaccine (malaria vaccine) · Biological: Measles-Rubella vaccine
daily multivitamin syrup from age 6 to 10 months
Dietary Supplement: Multivitamin syrup · Biological: R21-Matrix/M Vaccine (malaria vaccine) · Biological: Measles-Rubella vaccine
Iron syrup administered daily from 6 to 10 months of age.
Multivitamin syrup administered daily from 6 to 10 months of age.
R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.
Measles-Rubella vaccine administered at 9 months of age.
NANP-specific IgG
IgG antibodies targeting the NANP repeat region of the circumsporozoite protein (CSP)
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
Anti-measles IgG
IgG antibodies targeting measles antigen
Time frame: At 10 months of age (1 month after MR vaccine administration)
Anti-typhoid IgG
IgG antibodies targeting typhoid antigen
Time frame: At 10 months of age (1 month after Typhim VI administration)
C-terminal-specific IgG
IgG antibodies targeting the C-terminal region of CSP
Time frame: At 10 months of age (1 month after 3rd R21/Matrix-M dose)
C-terminal-specific IgG
IgG antibodies targeting the C-terminal region of CSP
Time frame: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
C-terminal-specific IgG
IgG antibodies targeting the C-terminal region of CSP
Time frame: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
NANP-specific IgG
IgG antibodies targeting the NANP repeat region of CSP
Time frame: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
NANP-specific IgG
IgG antibodies targeting the NANP repeat region of CSP
Time frame: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
Full-length CSP-specific IgG
IgG antibodies targeting the full-length CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgM
IgM antibodies targeting the NANP repeat region of CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgA
IgA antibodies targeting the NANP repeat region of CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG4
IgG4 antibodies targeting the NANP repeat region of CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG3
IgG3 antibodies targeting the NANP repeat region of CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG2
IgG2 antibodies targeting the NANP repeat region of CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG1
IgG1 antibodies targeting the NANP repeat region of CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
IgG avidity to measles antigen
Avidity index for IgG binding to measles antigen
Time frame: At 10 months of age (1 month after MR vaccine administration)
IgG avidity to typhoid antigen
Avidity index for IgG binding to typhoid antigen
Time frame: At 10 months of age (1 month after Typhim VI administration)
IgG avidity to NANP-specific CSP
Avidity index for IgG binding to NANP CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
IgG avidity to C-terminal CSP
Avidity index for IgG binding to C-terminal CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
Full-length CSP-specific IgG seropositivity
Categorical (positive/negative)
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
C-terminal-specific IgG seropositivity
Categorical (positive/negative)
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
C-terminal-specific IgG seropositivity
Categorical (positive/negative)
Time frame: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
C-terminal-specific IgG seropositivity
Categorical (positive/negative)
Time frame: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
NANP-specific IgG seropositivity
Categorical (positive/negative)
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG seropositivity
Categorical (positive/negative)
Time frame: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
NANP-specific IgG seropositivity
Categorical (positive/negative)
Time frame: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
Inhibition of Plasmodium falciparum sporozoite-invasion of HC-04 hepatic cells
Exploratory in vitro assay on IgG functionality in lowest and highest responders
Time frame: At 10 months of age (1 months after the 3rd R21/Matrix-M dose)
Opsonic phagocytosis of CSP-coated beads by THP-1 cells
Exploratory in vitro assay of IgG opsonization functionality in lowest and highest responders
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
Antibody-dependent cellular cytotoxicity (ADCC) by natural killer (NK) cells
Exploratory in vitro assay performed in lowest and highest responders
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
Antibody levels against a panel of antigens associated with malaria exposure in the previous year
Exploratory in all participants
Time frame: At 7 months of age (baseline)
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2027, 21 months after the start.
Of 76 non-industry interventional studies with no phase under Iron Deficiencies, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 26. This study's planned 21 months is above that.
Counting every sponsor, half of 88 studies reached it within 10 months; a quarter within 5 and three quarters within 26.
Start moved once since we started tracking on Sep 25, 2026: Jan 2026 → Mar 2026, on Nov 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Nicole Stoffel