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A Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market

NCT04199234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-07-26

No results posted yet for this study

Summary

The purpose of this study is to compare the frequency of appearance of the total clinical manifestations (expected adverse event: nausea, vomiting, heartburn, abdominal pain, gas/swelling, diarrhea, headache, shortness of breath, metallic taste and constipation) after consuming microencapsulated iron and comparator for 14 days.

Conditions

  • Supplement

Interventions

DIETARY_SUPPLEMENT

Experimental product consumption

Consumption of an encapsulated iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch

DIETARY_SUPPLEMENT

Comparator product consumption (Iron sulphate)

Consumption of iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch

Sponsors & Collaborators

  • Universidad Católica San Antonio de Murcia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2020-12-23
Completion
2021-03-08

Countries

  • Spain

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 NCT04199234 on ClinicalTrials.gov