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Analysis of the Effect of Iron Supplements on Iron Deficiency Anemia in Pregnancy

Primary Purpose

Iron Deficiency Anemia of Pregnancy, Iron Storage Disease

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Niferex
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia of Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: The patient was examined and delivered at the First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital of Shandong Province) Clinical diagnosis of ID(iron depletion) Clinical diagnosis of IDA(iron depletion anemia) In the second trimester of pregnancy (24-26 weeks of pregnancy) Must be able to swallow tablets Agree to participate in the trial and sign the informed consent. Exclusion Criteria: C-reactive protein in serum ≥5mg/L; Clinical diagnosis of Hypertensive disorders complicating pregnancy Clinical diagnosis of Gestational diabetes Clinical diagnosis of Hypothyroidism Clinical diagnosis of Chronic digestive system diseases Clinical diagnosis of Renal insufficiency Clinical diagnosis of psychiatric diseases Clinical diagnosis of fetal growth restriction Clinical diagnosis of placenta previa Clinical diagnosis of placental abruption Clinical diagnosis of fetal distress Clinical diagnosis of premature rupture of membranes Clinical diagnosis of Thalassemia Clinical diagnosis of Hemoglobinopathy Use anticoagulant drugs for treatment Smoking Excessive drinking Clinical diagnosis of Hemorrhoids Take acid inhibitor

Sites / Locations

  • Shandong Provincial Qianfoshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

150mg QD

150mg QOD

300mg QD

300mg QOD

Intravenous iron supplement

Arm Description

Each subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every day.

Each subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every other day.

Each subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every day.

Each subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every other day.

Each subject was given intravenous iron supplements according to the instructions

Outcomes

Primary Outcome Measures

Ferritin
Concentration of Ferritin in serum in late pregnancy
Elevated hemoglobin value
Elevated hemoglobin value between 24 and 41 weeks of gestation

Secondary Outcome Measures

Hemoglobin
Concentration of Hemoglobin value in whole blood
ferritin
Concentration of ferritin value in serum
serum iron
Concentration of serum iron value in serum
transferrin saturation
Concentration of transferrin saturation value in serum
total iron binding force
total iron binding force in serum
reticulocyte count
reticulocyte count in whole blood
Correction rate of iron deficiency anemia during pregnancy
Correction rate of ferritin deficiency
Adverse reaction rate
Rate of Adverse reaction such as Vomiting, nausea, constipation, diarrhea or allergy
Correction rate of ferritin deficiency
Correction rate of ferritin deficiency

Full Information

First Posted
March 2, 2023
Last Updated
April 6, 2023
Sponsor
Qianfoshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05804071
Brief Title
Analysis of the Effect of Iron Supplements on Iron Deficiency Anemia in Pregnancy
Official Title
Analysis of the Effect of Different Doses, Frequencies and Ways of Iron Supplements on Iron Deficiency Anemia in Pregnancy: a Randomized , Single Centered,Controlled, Single-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Subjects were tested for hemoglobin, ferritin, serum iron, transferrin saturation and reticulocyte count during routine prenatal examination at 24-26 weeks of gestation, and blood samples were taken for serum hepcidin detection in the laboratory and the values were recorded. Those who met the criteria were included in the study group, signed the informed consent form and randomized into groups, and were given different drug administration schemes (150mg orally every day, 300mg orally every day, 150mg orally every other day, 300mg orally every other day, intravenous). At the same time, each subject was given anemia diet education, and all subjects were given folic acid 400ug/d and vitamin C 0.5g/d orally during the treatment period. If the subjects were in the oral iron group, the same time of oral iron was determined as 20 o'clock ± 1 hour in the evening, and the oral iron was not taken with other drugs; If the subject is in the intravenous medication group, the medication is scheduled to be administered at a uniform time of 8 o'clock ± 1 hour in the morning. The above subjects were followed up. Hemoglobin, ferritin, serum iron, transferrin saturation and reticulocyte count were performed at 30-32 and 37 weeks of pregnancy and delivery, and blood samples were taken for serum hepcidin detection in the laboratory and the values were recorded. The adverse reactions were investigated with a questionnaire at the last prenatal examination before delivery. After full term delivery, the patient fills in the delivery information and enters it into the database. Finally, the data statistician and the above personnel used the blind method for statistical analysis and reached a conclusion.
Detailed Description
Subjects were tested for hemoglobin, ferritin, serum iron, transferrin saturation and reticulocyte count during routine prenatal examination at 24-26 weeks of gestation, and blood samples were taken for serum hepcidin detection in the laboratory and the values were recorded. Those who met the criteria were included in the study group, signed the informed consent form and randomized into groups, and were given different drug administration schemes (150mg orally every day, 300mg orally every day, 150mg orally every other day, 300mg orally every other day, intravenous). At the same time, each subject was given anemia diet education, and all subjects were given folic acid 400ug/d and vitamin C 0.5g/d orally during the treatment period. If the subjects were in the oral iron group, the same time of oral iron was determined as 20 o'clock ± 1 hour in the evening, and the oral iron was not taken with other drugs; If the subject is in the intravenous medication group, the medication is scheduled to be administered at a uniform time of 8 o'clock ± 1 hour in the morning. The above subjects were followed up. Hemoglobin, ferritin, serum iron, transferrin saturation and reticulocyte count were performed at 30-32 and 37 weeks of pregnancy and delivery, and blood samples were taken for serum hepcidin detection in the laboratory and the values were recorded. The adverse reactions were investigated with a questionnaire at the last prenatal examination before delivery. After full term delivery, the patient fills in the delivery information and enters it into the database. Finally, the data statistician and the above personnel used the blind method for statistical analysis and reached a conclusion. 1.1 Oral iron:NIFEREX®(Each granule contains 0.15g of polysaccharide iron complex ,Kremers Urban Pharmaceuticals Inc. ) 1.2 Daily iron supplement scheme (QD):Oral polysaccharide iron complex capsule 150mg/300mg daily. 1.3 Alternative iron supplement scheme(QOD):)Oral polysaccharide iron complex capsule 150mg/300mg every other day 2.1Intravenous iron supplement:Iron Isomaltoside Injection(5ml: 500mg,Wasserburger Arzneimittelwerk GmbH),Intravenous iron supplement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia of Pregnancy, Iron Storage Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
452 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
150mg QD
Arm Type
Active Comparator
Arm Description
Each subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every day.
Arm Title
150mg QOD
Arm Type
Active Comparator
Arm Description
Each subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every other day.
Arm Title
300mg QD
Arm Type
Active Comparator
Arm Description
Each subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every day.
Arm Title
300mg QOD
Arm Type
Active Comparator
Arm Description
Each subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every other day.
Arm Title
Intravenous iron supplement
Arm Type
Active Comparator
Arm Description
Each subject was given intravenous iron supplements according to the instructions
Intervention Type
Drug
Intervention Name(s)
Niferex
Other Intervention Name(s)
MonoFer
Intervention Description
Daily iron supplement scheme (QD):Oral polysaccharide iron complex capsule (Niferex)150mg/300mg daily. Alternative iron supplement scheme(QOD):Oral polysaccharide iron complex capsule(Niferex) 150mg/300mg every other day. Intravenous iron supplement(MonoFer):use as instructions
Primary Outcome Measure Information:
Title
Ferritin
Description
Concentration of Ferritin in serum in late pregnancy
Time Frame
37-41 weeks gestation
Title
Elevated hemoglobin value
Description
Elevated hemoglobin value between 24 and 41 weeks of gestation
Time Frame
37-41 weeks gestation
Secondary Outcome Measure Information:
Title
Hemoglobin
Description
Concentration of Hemoglobin value in whole blood
Time Frame
20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Title
ferritin
Description
Concentration of ferritin value in serum
Time Frame
20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Title
serum iron
Description
Concentration of serum iron value in serum
Time Frame
20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Title
transferrin saturation
Description
Concentration of transferrin saturation value in serum
Time Frame
20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Title
total iron binding force
Description
total iron binding force in serum
Time Frame
20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Title
reticulocyte count
Description
reticulocyte count in whole blood
Time Frame
20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Title
Correction rate of iron deficiency anemia during pregnancy
Description
Correction rate of ferritin deficiency
Time Frame
37-41 weeks gestation
Title
Adverse reaction rate
Description
Rate of Adverse reaction such as Vomiting, nausea, constipation, diarrhea or allergy
Time Frame
37-41 weeks gestation
Title
Correction rate of ferritin deficiency
Description
Correction rate of ferritin deficiency
Time Frame
37-41 weeks gestation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women of childbearing age who can be pregnant
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The patient was examined and delivered at the First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital of Shandong Province) Clinical diagnosis of ID(iron depletion) Clinical diagnosis of IDA(iron depletion anemia) In the second trimester of pregnancy (24-26 weeks of pregnancy) Must be able to swallow tablets Agree to participate in the trial and sign the informed consent. Exclusion Criteria: C-reactive protein in serum ≥5mg/L; Clinical diagnosis of Hypertensive disorders complicating pregnancy Clinical diagnosis of Gestational diabetes Clinical diagnosis of Hypothyroidism Clinical diagnosis of Chronic digestive system diseases Clinical diagnosis of Renal insufficiency Clinical diagnosis of psychiatric diseases Clinical diagnosis of fetal growth restriction Clinical diagnosis of placenta previa Clinical diagnosis of placental abruption Clinical diagnosis of fetal distress Clinical diagnosis of premature rupture of membranes Clinical diagnosis of Thalassemia Clinical diagnosis of Hemoglobinopathy Use anticoagulant drugs for treatment Smoking Excessive drinking Clinical diagnosis of Hemorrhoids Take acid inhibitor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Zhiwei, PH.D
Phone
13953109309
Email
zzw_sun@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Zhiwei, PH.D
Organizational Affiliation
Qianfoshan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shandong Provincial Qianfoshan Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shandong PQ Hospital, Ph.D
Phone
13953109309
Email
zzw_sun@163.com

12. IPD Sharing Statement

Learn more about this trial

Analysis of the Effect of Iron Supplements on Iron Deficiency Anemia in Pregnancy

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