Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492512
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-28
Brief Title:
Oral Iron Supplementation on Alternate vs Consecutive Days for Iron Deficiency Anemia in Pregnancy
Sponsor:
Southern Illinois University
Organization:
Southern Illinois University
Study Overview
Official Title:
Oral Iron Supplementation on Alternate vs Consecutive Days for Iron Deficiency Anemia in Pregnancy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This will be a randomized clinical trial Enrolled subjects will be randomized 11 into two study arms to receive either daily Group 1 or alternate day Group 2 supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
Detailed Description:
During the enrollment baseline visit subjects will undergo a blood draw to assess hemoglobin ferritin and soluble transferrin receptor sTfR levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms All ferrous sulfate oral tablets will be provided to patients by the investigators All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption preferably with a vitamin C rich product such as orange juice To minimize variability introduced by other potential iron sources prenatal vitamins that have the same amount and form of iron will be provided to both study groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None