Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 5:53 PM
Study NCT ID:
NCT05990166
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Sponsor:
Carleton University
Organization:
Study Overview
Official Title:
Randomised Controlled Trial to Assess the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
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:
None
Brief Summary:
The goal of this clinical trial is to determine if taking a mineral-enriched powder can raise blood iron levels compared to a placebo powder in reproductive-aged women with iron deficiency. The main questions it aims to answer are:
* Does the mineral-enriched powder raise blood iron levels compared to a placebo powder in women when it is taken every day for six months?
* How many participants still have iron deficiency after six months of taking the mineral-enriched powder compared to a placebo powder?
Participants in this clinical trial will drink the mineral-enriched powder containing ferrous iron and zinc sulphate monohydrate or a placebo powder mixed with 1 litre of water daily for six months. The placebo is a look-alike substance that does not contain active ingredients (iron and zinc). Participants will also have to:
* Complete an online "study diary" every two weeks for six months
* Provide a blood sample once a month for six months
* Attend three in-person visits with a researcher, at enrolment (baseline), midline (three months), and endline (six months)
* Complete three sets of online questionnaires (following each in-person visit)
* Complete three sets of dietary assessments (following each in-person visit)
* Provide three stool samples (following each in-person visit)
* Does the mineral-enriched powder raise blood iron levels compared to a placebo powder in women when it is taken every day for six months?
* How many participants still have iron deficiency after six months of taking the mineral-enriched powder compared to a placebo powder?
Participants in this clinical trial will drink the mineral-enriched powder containing ferrous iron and zinc sulphate monohydrate or a placebo powder mixed with 1 litre of water daily for six months. The placebo is a look-alike substance that does not contain active ingredients (iron and zinc). Participants will also have to:
* Complete an online "study diary" every two weeks for six months
* Provide a blood sample once a month for six months
* Attend three in-person visits with a researcher, at enrolment (baseline), midline (three months), and endline (six months)
* Complete three sets of online questionnaires (following each in-person visit)
* Complete three sets of dietary assessments (following each in-person visit)
* Provide three stool samples (following each in-person visit)
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: