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

Iron Deficiency Anemia of Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804071
• Other study ID #: YXL-KY-2023(006)
• Status: Recruiting
• Phase: Phase 4
• Start date: March 28, 2023
• Est. completion date: January 2025

Study information

• Verified date: April 2023
• Source: Qianfoshan Hospital
• Contact: Zhang Zhiwei, PH.D
• Phone: 13953109309
• Email: zzw_sun[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 452
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Hemochromatosis
• Hemosiderosis
• Iron Deficiency Anemia of Pregnancy

Intervention

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

Locations

Country	Name	City	State
China	Shandong Provincial Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ferritin	Concentration of Ferritin in serum in late pregnancy	37-41 weeks gestation
Primary	Elevated hemoglobin value	Elevated hemoglobin value between 24 and 41 weeks of gestation	37-41 weeks gestation
Secondary	Hemoglobin	Concentration of Hemoglobin value in whole blood	20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Secondary	ferritin	Concentration of ferritin value in serum	20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Secondary	serum iron	Concentration of serum iron value in serum	20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Secondary	transferrin saturation	Concentration of transferrin saturation value in serum	20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Secondary	total iron binding force	total iron binding force in serum	20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Secondary	reticulocyte count	reticulocyte count in whole blood	20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
Secondary	Correction rate of iron deficiency anemia during pregnancy	Correction rate of ferritin deficiency	37-41 weeks gestation
Secondary	Adverse reaction rate	Rate of Adverse reaction such as Vomiting, nausea, constipation, diarrhea or allergy	37-41 weeks gestation
Secondary	Correction rate of ferritin deficiency	Correction rate of ferritin deficiency	37-41 weeks gestation