Iron-deficiencyVINONCT04744818
Effects of Iron Supplementation on Pediatric Vaccine Response
A study testing Iron syrup and Multivitamin syrup in people with Iron-deficiency and Iron Deficiency Anemia, run by Jessica Rigutto at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 39 to 45 daysHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Vaccination
- What is being tested?
- Iron syrup and Multivitamin syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Feb 2021to 16 Oct 2023
- 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 39 to 45 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother at least ≥15 years of age.
- 6 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the detailed description
Two major pediatric public health goals in LMIC are increasing immunization effectiveness and reducing ID/IDA in children. ID/IDA affects many young children in Africa. Current guidelines do not recommend routine testing of hemoglobin in early infancy, as it is generally believed that most infants are born with adequate iron stores to last 6 months. However, many African infants are born with low iron stores and ID/IDA may develop earlier than generally appreciated, within 2-3 months after birth. 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. Despite lower efficacy in LMIC, these vaccines provide a major benefit because the disease burden is so high; however, if approaches can be found to improve immunogenicity, these vaccines would be even more powerful.
For this study, 6 weeks old infants will be randomly assigned to two study groups. Group 1 will receive iron at time of pediatric vaccinations from age 6-24 weeks. Group 2 will receive no iron at time of pediatric vaccinations. All infants will receive a multivitamin syrup from age 6-24 weeks. All infants remaining ID/IDA at age 24 weeks will receive iron. Infants will be followed-up until age 52 weeks.
- Conditions
- Iron-deficiency, Iron Deficiency Anemia, Vaccination, Pediatric ALL
- Being tested
- Iron syrup, Multivitamin syrup
- Medical subject headings
- Anemia, Iron-Deficiency, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron syrupDietary supplement
Daily supplementation with iron
Multivitamin syrupDietary supplement
Daily supplementation with multivitamins
| Study group | Role | What they receive |
|---|---|---|
| Immediate iron treatment | Active comparator | Iron and multivitamin syrup Receives: Dietary Supplement: Iron syrup; Dietary Supplement: Multivitamin syrup |
| Delayed iron treatment | Placebo comparator | Multivitamin syrup Receives: Dietary Supplement: Multivitamin syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pertussis antibody profile
Measured: from 6 to 24 weeks
Diphtheria antibody profile
Measured: from 6 to 24 weeks
Secondary outcomes (61)
antiviral immunoglobulin G response
Immunoassay
Measured: 6 weeks of age
antiviral immunoglobulin G response
Immunoassay
Measured: 24 weeks of age
infant antiviral immunoglobulin G response
Immunoassay
Measured: 52 weeks of age
immune cell populations
number and type of immune cells
Measured: 6 weeks of age
immune cell populations
number and type of immune cells
Measured: 24 weeks of age
immune cell populations
number and type of immune cells
Measured: 52 weeks of age
Proteomics
Proteins involved in immune response
Measured: 6 weeks of age
Proteomics
Proteins involved in immune response
Measured: 24 weeks of age
Proteomics
Proteins involved in immune response
Measured: 52 weeks of age
Transcriptomics
Genes involved in immune response
Measured: 24 weeks of age
Intestinal fatty acid binding protein
Gut inflammation
Measured: 6 weeks of age
Intestinal fatty acid binding protein
Gut inflammation
Measured: 14 weeks of age
Intestinal fatty acid binding protein
Gut inflammation
Measured: 24 weeks of age
Calprotectin
Gut inflammation
Measured: 6 weeks of age
Calprotectin
Gut inflammation
Measured: 14 weeks of age
Calprotectin
Gut inflammation
Measured: 24 weeks of age
Hemoglobin
Measured: 6 weeks of age
Hemoglobin
Measured: 14 weeks of age
Hemoglobin
Measured: 24 weeks of age
Hemoglobin
Measured: 38 weeks of age
Hemoglobin
Measured: 52 weeks of age
Plasma iron
Measured: 6 weeks of age
Plasma iron
Measured: 14 weeks of age
Plasma iron
Measured: 24 weeks of age
Plasma iron
Measured: 38 weeks of age
Plasma iron
Measured: 52 weeks of age
Plasma ferritin
Measured: 6 weeks of age
Plasma ferritin
Measured: 14 weeks of age
Plasma ferritin
Measured: 24 weeks of age
Plasma ferritin
Measured: 38 weeks of age
Plasma ferritin
Measured: 52 weeks of age
soluble transferrin receptor
Measured: 6 weeks of age
soluble transferrin receptor
Measured: 14 weeks of age
soluble transferrin receptor
Measured: 24 weeks of age
soluble transferrin receptor
Measured: 38 weeks of age
soluble transferrin receptor
Measured: 52 weeks of age
C-reactive protein
Measured: 6 weeks of age
C-reactive protein
Measured: 14 weeks of age
C-reactive protein
Measured: 24 weeks of age
C-reactive protein
Measured: 38 weeks of age
C-reactive protein
Measured: 52 weeks of age
Alpha-glycoprotein
Measured: 6 weeks of age
Alpha-glycoprotein
Measured: 14 weeks of age
Alpha-glycoprotein
Measured: 24 weeks of age
Alpha-glycoprotein
Measured: 38 weeks of age
Alpha-glycoprotein
Measured: 52 weeks of age
Tetanus antibody profile
Measured: from 6 to 24 weeks
Haemophilus influenzae b antibody profile
Measured: from 6 to 24 weeks
Pneumococcus antibody profile
Measured: from 6 to 24 weeks
Rotavirus antibody profile
Measured: from 6 to 24 weeks
Polio antibody profile
Measured: from 6 to 24 weeks
Anti-vaccine antibody titers
Measured: 38 weeks of age
Anti-vaccine antibody titers
Measured: 52 weeks of age
Anti-vaccine seroconversion
Measured: 14 weeks of age
Anti-vaccine seroconversion
Measured: 24 weeks of age
Anti-vaccine seroconversion
Measured: 38 weeks of age
Anti-vaccine seroconversion
Measured: 52 weeks of age
Anti-vaccine antibody avidity index
percentage of antibodies that remain bound to beads
Measured: 14 weeks of age
Anti-vaccine antibody avidity index
percentage of antibodies that remain bound to beads
Measured: 24 weeks of age
Anti-vaccine antibody avidity index
percentage of antibodies that remain bound to beads
Measured: 38 weeks of age
Anti-vaccine antibody avidity index
percentage of antibodies that remain bound to beads
Measured: 52 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start7 Feb 2021
- Primary completion3 Apr 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessica Rigutto
- Sponsor type
- University, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology, Karolinka Institute Sweden, University of Oxford, National Institute for Public Health and the Environment (RIVM)
- Responsible party
- Sponsor-investigator, Jessica Rigutto, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744818
- Sponsor's protocol ID
- VINO
- Acronym
- VINO
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2021
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Iron Supplementation on Pediatric Vaccine Response
- ClinicalTrials.gov ID
- NCT04744818
- Acronym / sponsor ID
- VINO / VINO
- Conditions
- Iron-deficiency, Iron Deficiency Anemia, Vaccination, Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Jessica RiguttoUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology, Karolinka Institute Sweden, University of Oxford, National Institute for Public Health and the Environment (RIVM)
- Study start
- 7 Feb 2021 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Two major pediatric public health goals in LMIC are increasing immunization effectiveness and reducing ID/IDA in children. ID/IDA affects many young children in Africa. Current guidelines do not recommend routine testing of hemoglobin in early infancy, as it is generally believed that most infants are born with adequate iron stores to last 6 months. However, many African infants are born with low iron stores and ID/IDA may develop earlier than generally appreciated, within 2-3 months after birth. 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. Despite lower efficacy in LMIC, these vaccines provide a major benefit because the disease burden is so high; however, if approaches can be found to improve immunogenicity, these vaccines would be even more powerful.
For this study, 6 weeks old infants will be randomly assigned to two study groups. Group 1 will receive iron at time of pediatric vaccinations from age 6-24 weeks. Group 2 will receive no iron at time of pediatric vaccinations. All infants will receive a multivitamin syrup from age 6-24 weeks. All infants remaining ID/IDA at age 24 weeks will receive iron. Infants will be followed-up until age 52 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate iron treatment | Active comparator | Dietary Supplement: Iron syrup, Dietary Supplement: Multivitamin syrupIron and multivitamin syrup |
| Delayed iron treatment | Placebo comparator | Dietary Supplement: Multivitamin syrupMultivitamin syrup |
Who may qualify
- Ages
- 39 to 45 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Mother at least ≥15 years of age.
- 6 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron syrupDaily supplementation with iron | Dietary supplement | Immediate iron treatment |
| Multivitamin syrupDaily supplementation with multivitamins | Dietary supplement | Delayed iron treatment, Immediate iron treatment |
Primary outcome
Pertussis antibody profile
Time frame: from 6 to 24 weeks
Diphtheria antibody profile
Time frame: from 6 to 24 weeks
61 secondary outcomes
antiviral immunoglobulin G response
Time frame: 6 weeks of age
antiviral immunoglobulin G response
Time frame: 24 weeks of age
infant antiviral immunoglobulin G response
Time frame: 52 weeks of age
immune cell populations
Time frame: 6 weeks of age
immune cell populations
Time frame: 24 weeks of age
immune cell populations
Time frame: 52 weeks of age
Proteomics
Time frame: 6 weeks of age
Proteomics
Time frame: 24 weeks of age
Proteomics
Time frame: 52 weeks of age
Transcriptomics
Time frame: 24 weeks of age
Intestinal fatty acid binding protein
Time frame: 6 weeks of age
Intestinal fatty acid binding protein
Time frame: 14 weeks of age
Intestinal fatty acid binding protein
Time frame: 24 weeks of age
Calprotectin
Time frame: 6 weeks of age
Calprotectin
Time frame: 14 weeks of age
Calprotectin
Time frame: 24 weeks of age
Hemoglobin
Time frame: 6 weeks of age
Hemoglobin
Time frame: 14 weeks of age
Hemoglobin
Time frame: 24 weeks of age
Hemoglobin
Time frame: 38 weeks of age
Hemoglobin
Time frame: 52 weeks of age
Plasma iron
Time frame: 6 weeks of age
Plasma iron
Time frame: 14 weeks of age
Plasma iron
Time frame: 24 weeks of age
Plasma iron
Time frame: 38 weeks of age
Plasma iron
Time frame: 52 weeks of age
Plasma ferritin
Time frame: 6 weeks of age
Plasma ferritin
Time frame: 14 weeks of age
Plasma ferritin
Time frame: 24 weeks of age
Plasma ferritin
Time frame: 38 weeks of age
Plasma ferritin
Time frame: 52 weeks of age
soluble transferrin receptor
Time frame: 6 weeks of age
soluble transferrin receptor
Time frame: 14 weeks of age
soluble transferrin receptor
Time frame: 24 weeks of age
soluble transferrin receptor
Time frame: 38 weeks of age
soluble transferrin receptor
Time frame: 52 weeks of age
C-reactive protein
Time frame: 6 weeks of age
C-reactive protein
Time frame: 14 weeks of age
C-reactive protein
Time frame: 24 weeks of age
C-reactive protein
Time frame: 38 weeks of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron syrup and Multivitamin syrup in people with Iron-deficiency and Iron Deficiency Anemia, run by Jessica Rigutto at 2 sites in 2 countries.
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 14 inclusion and 0 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Switzerland. 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?
Pertussis antibody profile (time frame: from 6 to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2024.