Iron Babies Pilot Supplementation Trial

Iron-deficiency Clinical Trial

— Iron Babies  

Official title:

Enhancing Brain Development by Early Iron Supplementation of African Infants: An Enabling Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751994
• Other study ID #: LEO 19092
• Status: Completed
• Phase: Phase 3
• Start date: August 3, 2021
• Est. completion date: March 9, 2022

Study information

• Verified date: May 2022
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

2-arm, double blind, placebo controlled, randomised trial, with 50 6-week-old infants per arm randomized to 98 days of daily iron (1.5mg/kg/day as ferrous sulphate) or placebo drops

Description:

Healthy infants will be randomised to receive daily supplementation from 6-20wks of either a) iron drops or b) placebo drops. Infants with significant illness or any clinical syndromes that would affect interpretation will be excluded. Low birthweight infants and infants born prematurely will not be excluded. Venous blood samples will be collected at enrollment (age 6 weeks) and after 14 weeks (98 days) of iron/placebo supplementation.

Participants will be visited daily in their villages by Fieldworkers (FW) to administer the iron/placebo dose and will interview mothers to complete a short health questionnaire. The iron will be dosed at 75% of WHO guideline dose (ie 1.5mg/kg/day). Weekly, a more detailed morbidity and breastfeeding questionnaires will be administered. Infants will be weighed and measured monthly, along with a faecal sample being taken.

During the daily visits, the FWs will record any adverse events (AEs) and ensure the safety of participants. If a child is found unwell or if the mother/guardian reports that the child is unwell, the study nurse will check on the child and decide on treatment/referral to the nearest health centre

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 10 Weeks

Eligibility

Inclusion Criteria:

• Infants (male or female) from 6 weeks to 10 weeks of age.

• Breast fed infants (with plans to continue breastfeeding through 6 months of age).

• Parent/guardian with participant reside in study site area and are able and willing to adhere to all protocol visits and procedures (willingness to stay in the study area for the 14 weeks of supplementation).

• Healthy with no current illness and no chronic health problems.

• Signed or fingerprinted informed consent obtained from participants parent/guardian

Exclusion Criteria:

• Low birthweight babies (ie less than 2.5kg at birth) or babies born prematurely (ie less than 37 weeks) will NOT be excluded.

• Formula fed infants or those planning to terminate exclusive breast feeding before 6months of age.

• Acute illness (once acute illness is resolved, if appropriate, as per investigator assessment, participant may be re-revaluated for eligibility)

• Fever (for eligibility purpose defined as a body temperature greater than 37.5°C or mother report of fever) within 3 days prior to study initiation (once fever/acute illness is resolved, if appropriate, as per investigator assessment, participant may be re-revaluated for eligibility).

• Administration of any investigational drug within 30 days prior to study initiation or planned administration during the study period.

• Unwilling to avoid (their child to avoid) the ingestion of supplements or herbal/other traditional medications during the study period.

• Any history of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease).

• Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.

• History of meningitis, seizures, Guillain-Barre´ syndrome, or other neurological disorders.

• Any condition that in the opinion of the investigator might compromise the safety or well- being of the participant or compromise adherence to protocol procedures

Related Conditions & MeSH terms

• Anaemia in Early Infancy
• Anemia
• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

Dietary Supplement:
• Iron drops/Ferrous sulphate
participant will consume daily drops of iron
• Placebo drops
Participants will consume daily drops of placebo

Locations

Country	Name	City	State
Gambia	Keneba Field Station	Keneba

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum iron level	Serum iron concentration at days 0 and 99	at day 0 and at day 99
Secondary	Haemoglobin concentration	Haemoglobin concentration at days 0 and 99	at day 0 and at day 99
Secondary	Percentage of infants with anaemia	Percentage of infants with anaemia (defined as: Hb< 110g/L, )	at day 99
Secondary	breast feeding	Duration of breast feeding assessed weekly, up to study day 98.	weekly up to week 14
Secondary	maternal reported illnesses	Proportion of maternal-reported illnesses assessed daily up to study day 99.	daily up to day 99
Secondary	adverse events assessment	Proportion of adverse events assessed daily, up to study day 99	daily up to day 99
Secondary	Serious adverse events (SAE) assessment	Proportion of serious adverse events assessed daily, up to study day 99	daily up to day 99
Secondary	raised inflammatory markers assessment	Proportion of raised inflammatory markers (CRP/AGP)	after 98 days of supplementation
Secondary	iron deficiency anemia (Hb < 11 g/dL & sTfR/logFerritin ratio < 2.0 and ferritin < 12 ug/L or < 30 ug/L in the presence of inflammation	Proportion of children that are iron deficiency anaemia (Hb < 11 g/dL & sTfR/logFerritin ratio < 2.0 and ferritin < 12 ug/L or < 30 ug/L in the presence of inflammation)	at day 0 and day 99
Secondary	Fecal iron after supplementation	Fecal iron assessed at day 0 and day 99	day 0 and day 99
Secondary	Iron regulation	Hepcidin levels at day 0 and day 99	day 0 and day 99
Secondary	Reticulocytes at day 0 and day 99	Reticulocytes at day 0 and day 99	day 0 and day 99
Secondary	Erythropoietin at days 0 and 99	Erythropoietin at days 0 and 99	day 0 and 99
Secondary	Erythroferrone at days 0 and 99	Erythroferrone at days 0 and 99	day 0 and 99