MedTrace Logo

Evaluation of the Effects of Routine Iron Supplementation in Children on Gastrointestinal Iron Losses

NCT04721964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-07-27

No results posted yet for this study

Summary

Iron deficiency anaemia (IDA) is common among infants and young children in sub-Saharan Africa.Oral iron administration is usually recom-mended as cost effective measure to prevent and treat iron deficiency (ID) and IDA during childhood. In Kenya, national nutrition policies for anaemia prevention recommend a daily dose of 3-6 mg ele-mental iron per kg body weight if a child is diagnosed with anaemia.

Using a novel technology, recent research found increased iron losses during iron supplementation. In an explorative analysis of stool samples collected from Gambian toddlers (Speich et al., 2020), an increase in faecal iron losses during iron supplementation was reported. The present study is aiming to analyse a relationship between routine iron supplementation and increased faecal occult blood losses in 24 Kenyan children with anaemia and iron deficiency in a more structured manner.

Secondary objectives of the study are to measure and monitor iron and inflammatory status during the course of the study and to quantify long-term iron absorption and iron losses during a 12-weeks iron supplementation period, in order to put iron balance into relationship to occurring faecal occult blood losses during such an intervention.

Conditions

Interventions

DIETARY_SUPPLEMENT

Ferric ammonium citrate and ferrous fumarate syrup (Ranbaxy Ranferon-12 Syrup, Ranbaxy Laboratories, Gurgaon, India)

Daily supplementation with iron syrup for 13 weeks. The dosage will be calculated based on body weight and adjusted after 4 and 8 weeks of intervention

Sponsors & Collaborators

  • Jomo Kenyatta University of Agriculture and Technology

    collaborator OTHER

  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Nicole U Stoffel, PhD · ETH

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
23 Months
Max Age
29 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2021-06-16
Completion
2021-06-16

Countries

  • Kenya

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04721964 on ClinicalTrials.gov