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Safe and Efficacious Iron for Children in Kenya

NCT02073149 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2015-04-10

No results posted yet for this study

Summary

This study will determine whether the haemoglobin response to daily home fortification for 30 days with 3mg iron as NaFeEDTA is non-inferior to 12.5 mg iron as encapsulated ferrous fumarate.

Conditions

  • Anaemia

Interventions

DIETARY_SUPPLEMENT

Low-dose iron as NaFeEDTA

Daily home fortification for 30 days with 3 mg iron as NaFeEDTA, vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate)

DIETARY_SUPPLEMENT

Conventional dose iron as ferrous salt

Daily home fortification for 30 days with 12.5 mg iron as encapsulated ferrous fumarate, vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate)

DIETARY_SUPPLEMENT

Placebo

Daily home fortification for 30 days with vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate)

Sponsors & Collaborators

  • Maseno University

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Hans Verhoef, PhD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Kenya

Study Locations

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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 NCT02073149 on ClinicalTrials.gov