Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT04199234
Status:
COMPLETED
Last Update Posted:
2021-07-26
First Post:
2019-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market
Sponsor:
Universidad Católica San Antonio de Murcia
Organization:
Study Overview
Official Title:
A Randomized, Double Blind, Crossover Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRON
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: