Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014983
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-08-22
Brief Title:
Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements EASE-Iron a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
EASE-Iron
Brief Summary:
This two-arm double-blind randomized clinical trial will recruit 208 generally healthy low-risk pregnant individuals aged 19-42 years living in Vancouver Canada Participants will be randomized to receive one of two forms of iron ferrous fumarate or ferrous bisglycinate in addition to a prenatal multivitamin without iron daily during their pregnancy until delivery with optional continuation until 4 weeks postpartum for breastmilk sample collection Blood samples will be taken at baseline and again at 37 weeks gestation to assess how different forms of iron impact body iron stores Rectal swabs will also be taken at baseline and 37 weeks gestation to detect presence of harmful bacteria in the gut and quantify their abundance This research will inform more specific guidelines for optimal iron supplementation practices for the prevention and treatment of iron deficiency for both mother and baby
Detailed Description:
To address our primary aim of determining the optimal form of iron in prenatal supplements we seek to answer the following research questions
1 Does providing a more bioavailable form of iron 24 mg elemental iron as ferrous bisglycinate effectively increase ferritin concentration in maternal venous blood and umbilical cord blood as compared to the standard 24 mg elemental iron as ferrous fumarate
2 Does 12 weeks of 24 mg daily oral iron as ferrous fumarate increase biomarkers of potential harm gut inflammation gut pathogen abundance adverse side effects in pregnant individuals as compared to 24 mg daily oral iron as ferrous bisglycinate
Pregnant individuals 13-25 weeks gestation will be randomized to one of two trial arms to receive either 24 mg elemental iron as ferrous fumarate or 24 mg elemental iron as ferrous bisglycinate for a minimum of 12 weeks during pregnancy until delivery with optional continuation until 4-weeks postpartum for breastmilk collection All participants will also receive the standard form and dose of other critical micronutrients during pregnancy eg folate calcium through the provision of a prenatal multivitamin not containing iron
Interested individuals may undergo the informed consent process anytime prior to 25 weeks gestation Once an individual indicates that they are interested in participating in the trial the individual will be assigned a unique study ID and a baseline visit will be scheduled
The baseline visit will occur between 13-25 weeks gestation and will involve discontinuation of current ironprenatal vitamin supplementation review and signing the informed consent form a scanned copy will be shared with the participant randomization to an iron group provision of study supplements completion of a baseline questionnaire measurement of weight and height a small blood draw and collection of a rectal swab sample
The intervention period is a minimum of 12 weeks from baseline at 13-25 weeks to delivery Participants will supplement daily with the iron and prenatal multivitamin supplements Monthly follow-up surveys will be sent to participants via email to check-in and receive updates regarding any changes to medical history or medication use
The endline visit will occur at approximately 37 weeks gestation and will involve collecting any remaining supplements for capsule counts and assessment of adherence a weight measurement a small blood draw collection of a rectal swab sample and completion of a short endline questionnaire
Optional continuation of study After the endline visit participants who are planning to breastfeed will have the option to continue supplementing with the study supplements until approximately 4 weeks postpartum at which time they will provide a small breastmilk sample
1 Does providing a more bioavailable form of iron 24 mg elemental iron as ferrous bisglycinate effectively increase ferritin concentration in maternal venous blood and umbilical cord blood as compared to the standard 24 mg elemental iron as ferrous fumarate
2 Does 12 weeks of 24 mg daily oral iron as ferrous fumarate increase biomarkers of potential harm gut inflammation gut pathogen abundance adverse side effects in pregnant individuals as compared to 24 mg daily oral iron as ferrous bisglycinate
Pregnant individuals 13-25 weeks gestation will be randomized to one of two trial arms to receive either 24 mg elemental iron as ferrous fumarate or 24 mg elemental iron as ferrous bisglycinate for a minimum of 12 weeks during pregnancy until delivery with optional continuation until 4-weeks postpartum for breastmilk collection All participants will also receive the standard form and dose of other critical micronutrients during pregnancy eg folate calcium through the provision of a prenatal multivitamin not containing iron
Interested individuals may undergo the informed consent process anytime prior to 25 weeks gestation Once an individual indicates that they are interested in participating in the trial the individual will be assigned a unique study ID and a baseline visit will be scheduled
The baseline visit will occur between 13-25 weeks gestation and will involve discontinuation of current ironprenatal vitamin supplementation review and signing the informed consent form a scanned copy will be shared with the participant randomization to an iron group provision of study supplements completion of a baseline questionnaire measurement of weight and height a small blood draw and collection of a rectal swab sample
The intervention period is a minimum of 12 weeks from baseline at 13-25 weeks to delivery Participants will supplement daily with the iron and prenatal multivitamin supplements Monthly follow-up surveys will be sent to participants via email to check-in and receive updates regarding any changes to medical history or medication use
The endline visit will occur at approximately 37 weeks gestation and will involve collecting any remaining supplements for capsule counts and assessment of adherence a weight measurement a small blood draw collection of a rectal swab sample and completion of a short endline questionnaire
Optional continuation of study After the endline visit participants who are planning to breastfeed will have the option to continue supplementing with the study supplements until approximately 4 weeks postpartum at which time they will provide a small breastmilk sample
Study Oversight
Has Oversight DMC:
None
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?:
None