NCT04744818

Brief Summary

ID/IDA affects many young children in Africa. Vaccines provide tremendous benefits in LMIC; however, they currently fail to reach their full potential. We need to better understand the causes of vaccine failure, in order to develop new strategies to improve vaccine immunogenicity. This study will contribute to children's health by: (1) providing updated guidelines to better define the prevalence of ID/IDA in early infancy, and its safe and effective control using iron; and (2) providing a new approach to improve response to pediatric vaccines in LMIC, by ensuring adequate iron status at time of vaccination.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

2.2 years

First QC Date

January 28, 2021

Last Update Submit

January 22, 2024

Conditions

Iron-deficiencyIron Deficiency AnemiaVaccinationPediatric ALL

Outcome Measures

Primary Outcomes (2)

  • Pertussis antibody profile

    from 6 to 24 weeks

  • Diphtheria antibody profile

    from 6 to 24 weeks

Secondary Outcomes (61)

  • antiviral immunoglobulin G response

    6 weeks of age

  • antiviral immunoglobulin G response

    24 weeks of age

  • infant antiviral immunoglobulin G response

    52 weeks of age

  • immune cell populations

    6 weeks of age

  • immune cell populations

    24 weeks of age

  • +56 more secondary outcomes

Other Outcomes (6)

  • Human milk oligosaccharide secretor type

    14 weeks of age

  • Erythrocyte zinc protoporphyrin

    6 weeks of age

  • Erythrocyte zinc protoporphyrin

    14 weeks of age

  • +3 more other outcomes

Study Arms (2)

Immediate iron treatment

ACTIVE COMPARATOR

Iron and multivitamin syrup

Dietary Supplement: Iron syrupDietary Supplement: Multivitamin syrup

Delayed iron treatment

PLACEBO COMPARATOR

Multivitamin syrup

Dietary Supplement: Multivitamin syrup

Interventions

Iron syrupDIETARY_SUPPLEMENT

Daily supplementation with iron

Immediate iron treatment
Multivitamin syrupDIETARY_SUPPLEMENT

Daily supplementation with multivitamins

Delayed iron treatmentImmediate iron treatment

Eligibility Criteria

Age39 Days - 45 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mother at least ≥15 years of age.
  • weeks (+/- 3 days) of age
  • Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) \>61 μmol/mol heme)
  • With or without anemia, but not severely anemic (Hb \>70 g/L)
  • No malaria
  • No medical condition that precludes study involvement
  • Mother HIV negative
  • Vaginal delivery
  • No iron supplementation prior to study enrolment
  • Not wasted (length for height z score of ≥-2)
  • Not underweight (weight for age z score ≥-2)
  • From the hospital record, term or late preterm delivery (≥34 weeks)
  • Full-time breastfed at least until the screening
  • No vaccines beyond the birth dose of OPV and BCG prior to enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Msambweni County Referral Hospital

Msambweni, Kwale County, Kenya

Location

Human Nutrition Laboratory ETH Zurich

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Nicole Stoffel

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 9, 2021

Study Start

February 7, 2021

Primary Completion

April 3, 2023

Study Completion

October 16, 2023

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)CH(1)