NCT04199234

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

A Randomized, Double Blind, Crossover Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Universidad Católica San Antonio de Murcia · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subjects will consume a daily dose once per day for 14 days with a washout period of two menstrual cycles between the two products. After this washout period, subjects will return to the clinical and will undergo identical procedures with counter order of the intervention. Each day of the study will be recorded in a diary by each subject. Participants will be requested not to change their regular life habits and diet during the entire study.

Conditions

• Supplement

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-12-23
• Completion: 2021-03-08
• First posted: 2019-12-13
• Last updated: 2021-07-26

Locations

1 site across 1 country: Spain