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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Iron Deficiency Anemia of Pregnancy, Iron Storage Disease

Intervention / Treatment
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* Drug: Niferex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 150mg QD<br>Each subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every day. | Drug: Niferex<br>* 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<br>* Other names: MonoFer;|
| Active Comparator: 150mg QOD<br>Each subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every other day. | Drug: Niferex<br>* 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<br>* Other names: MonoFer;|
| Active Comparator: 300mg QD<br>Each subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every day. | Drug: Niferex<br>* 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<br>* Other names: MonoFer;|
| Active Comparator: 300mg QOD<br>Each subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every other day. | Drug: Niferex<br>* 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<br>* Other names: MonoFer;|
| Active Comparator: Intravenous iron supplement<br>Each subject was given intravenous iron supplements according to the instructions | Drug: Niferex<br>* 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<br>* Other names: MonoFer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin | Concentration of Ferritin in serum in late pregnancy | 37-41 weeks gestation | 
| Elevated hemoglobin value | Elevated hemoglobin value between 24 and 41 weeks of gestation | 37-41 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Concentration of Hemoglobin value in whole blood | 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation | 
| ferritin | Concentration of ferritin value in serum | 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation | 
| serum iron | Concentration of serum iron value in serum | 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation | 
| transferrin saturation | Concentration of transferrin saturation value in serum | 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation | 
| total iron binding force | total iron binding force in serum | 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation | 
| reticulocyte count | reticulocyte count in whole blood | 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation | 
| Correction rate of iron deficiency anemia during pregnancy | Correction rate of ferritin deficiency | 37-41 weeks gestation | 
| Adverse reaction rate | Rate of Adverse reaction such as Vomiting, nausea, constipation, diarrhea or allergy | 37-41 weeks gestation | 
| Correction rate of ferritin deficiency | Correction rate of ferritin deficiency | 37-41 weeks gestation |