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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Iron Deficiency Anemia of Pregnancy; Iron Storage Disease
• Intervention / Treatment: Drug: Niferex

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

• Study Type: Interventional
• Enrollment (Anticipated): 452
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhang Zhiwei, PH.D; Phone Number: 13953109309; Email: zzw_sun@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • ShanDong Provincial QianFoShan Hospital
      • Contact: Shandong PQ Hospital, Ph.D; Phone Number: 13953109309; Email: zzw_sun@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Study Chair: Zhang Zhiwei, PH.D, Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Metabolism, Inborn Errors; Metal Metabolism, Inborn Errors; Iron Overload; Anemia, Iron-Deficiency; Anemia; Hemochromatosis; Hemosiderosis; Deficiency Diseases
• Other Study ID Numbers: YXL-KY-2023（006）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No