Effects of Iron Supplementation on Pediatric Vaccine Response

Iron Deficiency Anemia Clinical Trial

— VINO  

Official title:

Effects of Iron Supplementation on Pediatric Vaccine Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744818
• Other study ID #: VINO
• Status: Completed
• Phase: N/A
• Start date: February 7, 2021
• Est. completion date: October 16, 2023

Study information

• Verified date: January 2024
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: October 16, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 39 Days to 45 Days

Eligibility

Inclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Iron-deficiency
• Pediatric ALL
• Vaccination

Intervention

Dietary Supplement:
• Iron syrup
Daily supplementation with iron
• Multivitamin syrup
Daily supplementation with multivitamins

Locations

Country	Name	City	State
Kenya	Msambweni County Referral Hospital	Msambweni	Kwale
Switzerland	Human Nutrition Laboratory ETH Zurich	Zürich

Sponsors (5)

Lead Sponsor	Collaborator
Jessica Rigutto	Jomo Kenyatta University of Agriculture and Technology Kenya, Karolinka Institute Sweden, National Institute for Public Health and Environment Netherlands, University of Oxford

Countries where clinical trial is conducted

Kenya,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Human milk oligosaccharide secretor type	secretor yes or no	14 weeks of age
Other	Erythrocyte zinc protoporphyrin		6 weeks of age
Other	Erythrocyte zinc protoporphyrin		14 weeks of age
Other	Erythrocyte zinc protoporphyrin		24 weeks of age
Other	Erythrocyte zinc protoporphyrin		38 weeks of age
Other	Erythrocyte zinc protoporphyrin		52 weeks of age
Primary	Pertussis antibody profile		from 6 to 24 weeks
Primary	Diphtheria antibody profile		from 6 to 24 weeks
Secondary	antiviral immunoglobulin G response	Immunoassay	6 weeks of age
Secondary	antiviral immunoglobulin G response	Immunoassay	24 weeks of age
Secondary	infant antiviral immunoglobulin G response	Immunoassay	52 weeks of age
Secondary	immune cell populations	number and type of immune cells	6 weeks of age
Secondary	immune cell populations	number and type of immune cells	24 weeks of age
Secondary	immune cell populations	number and type of immune cells	52 weeks of age
Secondary	Proteomics	Proteins involved in immune response	6 weeks of age
Secondary	Proteomics	Proteins involved in immune response	24 weeks of age
Secondary	Proteomics	Proteins involved in immune response	52 weeks of age
Secondary	Transcriptomics	Genes involved in immune response	24 weeks of age
Secondary	Intestinal fatty acid binding protein	Gut inflammation	6 weeks of age
Secondary	Intestinal fatty acid binding protein	Gut inflammation	14 weeks of age
Secondary	Intestinal fatty acid binding protein	Gut inflammation	24 weeks of age
Secondary	Calprotectin	Gut inflammation	6 weeks of age
Secondary	Calprotectin	Gut inflammation	14 weeks of age
Secondary	Calprotectin	Gut inflammation	24 weeks of age
Secondary	Hemoglobin		6 weeks of age
Secondary	Hemoglobin		14 weeks of age
Secondary	Hemoglobin		24 weeks of age
Secondary	Hemoglobin		38 weeks of age
Secondary	Hemoglobin		52 weeks of age
Secondary	Plasma iron		6 weeks of age
Secondary	Plasma iron		14 weeks of age
Secondary	Plasma iron		24 weeks of age
Secondary	Plasma iron		38 weeks of age
Secondary	Plasma iron		52 weeks of age
Secondary	Plasma ferritin		6 weeks of age
Secondary	Plasma ferritin		14 weeks of age
Secondary	Plasma ferritin		24 weeks of age
Secondary	Plasma ferritin		38 weeks of age
Secondary	Plasma ferritin		52 weeks of age
Secondary	soluble transferrin receptor		6 weeks of age
Secondary	soluble transferrin receptor		14 weeks of age
Secondary	soluble transferrin receptor		24 weeks of age
Secondary	soluble transferrin receptor		38 weeks of age
Secondary	soluble transferrin receptor		52 weeks of age
Secondary	C-reactive protein		6 weeks of age
Secondary	C-reactive protein		14 weeks of age
Secondary	C-reactive protein		24 weeks of age
Secondary	C-reactive protein		38 weeks of age
Secondary	C-reactive protein		52 weeks of age
Secondary	Alpha-glycoprotein		6 weeks of age
Secondary	Alpha-glycoprotein		14 weeks of age
Secondary	Alpha-glycoprotein		24 weeks of age
Secondary	Alpha-glycoprotein		38 weeks of age
Secondary	Alpha-glycoprotein		52 weeks of age
Secondary	Tetanus antibody profile		from 6 to 24 weeks
Secondary	Haemophilus influenzae b antibody profile		from 6 to 24 weeks
Secondary	Pneumococcus antibody profile		from 6 to 24 weeks
Secondary	Rotavirus antibody profile		from 6 to 24 weeks
Secondary	Polio antibody profile		from 6 to 24 weeks
Secondary	Anti-vaccine antibody titers		38 weeks of age
Secondary	Anti-vaccine antibody titers		52 weeks of age
Secondary	Anti-vaccine seroconversion		14 weeks of age
Secondary	Anti-vaccine seroconversion		24 weeks of age
Secondary	Anti-vaccine seroconversion		38 weeks of age
Secondary	Anti-vaccine seroconversion		52 weeks of age
Secondary	Anti-vaccine antibody avidity index	percentage of antibodies that remain bound to beads	14 weeks of age
Secondary	Anti-vaccine antibody avidity index	percentage of antibodies that remain bound to beads	24 weeks of age
Secondary	Anti-vaccine antibody avidity index	percentage of antibodies that remain bound to beads	38 weeks of age
Secondary	Anti-vaccine antibody avidity index	percentage of antibodies that remain bound to beads	52 weeks of age