The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.
FER-IDIP
2 other identifiers
interventional
58
1 country
1
Brief Summary
In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2022
CompletedFirst Submitted
Initial submission to the registry
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 14, 2022
March 1, 2022
11 months
February 15, 2022
March 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Haemoglobin level
The main endpoint of the study is the difference in haemoglobin level from baseline to 6 weeks as a continuous variable.
6 weeks after start treatment
Secondary Outcomes (7)
Side effects
6 weeks after start treatment
Therapy compliance
6 weeks after start treatment
Haemoglobin level at time of delivery
At time of delivery
Term of delivery
At delivery
Birth weight
At delivery
- +2 more secondary outcomes
Study Arms (2)
Intermittent
EXPERIMENTALThis group will receive ferrous fumarate 200mg intermittent three times a week on alternate days.
Daily
ACTIVE COMPARATORThis group will receive ferrous fumarate 200mg once daily.
Interventions
Eligibility Criteria
You may qualify if:
- Pregnant women of 18 years and older
- Iron deficiency anaemia (defined as: Anaemia (haemoglobin lower than cut-off value) AND mean corpuscular volume (MCV) 70-85 fl OR ferritin \<30ug/L) OR mean corpuscular volume (MCV) \< 70fl / hemoglobinopathy is ruled out.
- Adequate mental health
- Good command of the Dutch language
- No participation in other research with medication
- Informed consent
You may not qualify if:
- Start of iron supplementation at pregnancy duration \> 37 weeks (because of the limited time to achieve an increase in haemoglobin).
- History of bariatric surgery, inflammatory bowel disease, coeliac disease or Helicobacter pylori infection (because of malabsorption of iron).
- Patients who received blood transfusion or parental iron supplementation during the 3 months prior to screening (because of the effect on the haemoglobin level).
- Patients with significant bleeding, blood donation or surgery during pregnancy (because of the effect on the haemoglobin level).
- Allergy for iron.
- Anaemia of other cause, such as a hemoglobinopathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Martini Hospital Groningen
Groningen, 9728 NT, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- drs
Study Record Dates
First Submitted
February 15, 2022
First Posted
March 14, 2022
Study Start
January 7, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
March 14, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share