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NCT02254460

Investigation of Iron Uptake From Micronutrient Fortified Powder Versus From Tailored Control in Milk

Completed NA Results posted Last updated 11 July 2017
What this trial tests

NA trial testing Test in Growth and Development in 25 participants. Completed in 8 March 2013.

Timeline
6 February 2013
Primary endpoint
1 March 2013
8 March 2013

Quick facts

Lead sponsorGlaxoSmithKline
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposebasic science
Enrollment25
Start date6 February 2013
Primary completion1 March 2013
Estimated completion8 March 2013
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 7 to 10, any sex, with Growth and Development. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fractional Iron Absorption Primary · Day 15

Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.

GroupValue95% CI
Test2.08± 1.263
Control1.25± 0.922

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test
Serious: 0/25 (0%)
Deaths:
Control
Serious: 0/24 (0%)
Deaths:
Other adverse events (1 terms — click to expand)

ReactionSystemTestControl
GastritisGastrointestinal disorders

Data from ClinicalTrials.gov NCT02254460 adverse events section.

Sponsor's own description

The present study supplements iron as part of multiple micro-nutrient supplementation to demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake of key micronutrients like iron due to unique nature of the given matrix, as compared to intake of iron alone in milk.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Test

Trials testing the same drug.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02254460.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing