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Trial - NCT05919472


Column Value
Trial registration number NCT05919472
Full text link
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05919472

First author
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Giulia Pironaci, MSc

Contact
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

giulia.pironaci@hest.ethz.ch

Registration date
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

2023-06-26

Recruitment status
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

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
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

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 pregnant (confirmed by rapid test during screening) or lactating. malaria (confirmed by rapid test) à study start will be postponed

Number of arms
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Prof Simon Karanja

Inclusion age min
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

49

Countries
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Kenya

Type of patients
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

180

primary outcome
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Anti-MenACWY IgG concentrations at study end;Anti-S1 and anti-RBD IgG concentrations against SARS-COV-2 at study end;Baseline anti-strike (S1) immunoglobulin (IgG) and anti-receptor-binding domain (RBD) IgG concentrations against severe acute respiratory syndrome (SARS)-Coronavirus (COV)-2;Baseline IgG concentration against meningococcal serogroups A, C, W, and Y (anti-MenACWY IgG)

Notes
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : June 28, 2023, 4 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 2753, "treatment_name": "Ad26.cov2.s+menacwy vaccine", "treatment_type": "Non replicating viral vector+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Oral iron supplementation (pre-treatment) ", "treatment_id": 2752, "treatment_name": "Ad26.cov2.s+iron+menacwy vaccine", "treatment_type": "Non replicating viral vector+vitamins and dietary supplements+non covid vaccine", "pharmacological_treatment": "Vaccine+pharmacological treatment+non covid vaccine"}, {"arm_notes": "Oral iron supplementation (simultaneous treatment) ", "treatment_id": 2752, "treatment_name": "Ad26.cov2.s+iron+menacwy vaccine", "treatment_type": "Non replicating viral vector+vitamins and dietary supplements+non covid vaccine", "pharmacological_treatment": "Vaccine+pharmacological treatment+non covid vaccine"}]