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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05804071
Enrollment
452
Registered
2023-04-07
Start date
2023-03-28
Completion date
2025-01-31
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia of Pregnancy, Iron Storage Disease

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

Interventions

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

Sponsors

Qianfoshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ferritin37-41 weeks gestationConcentration of Ferritin in serum in late pregnancy
Elevated hemoglobin value37-41 weeks gestationElevated hemoglobin value between 24 and 41 weeks of gestation

Secondary

MeasureTime frameDescription
serum iron20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestationConcentration of serum iron value in serum
transferrin saturation20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestationConcentration of transferrin saturation value in serum
total iron binding force20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestationtotal iron binding force in serum
Hemoglobin20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestationConcentration of Hemoglobin value in whole blood
Correction rate of iron deficiency anemia during pregnancy37-41 weeks gestationCorrection rate of ferritin deficiency
Adverse reaction rate37-41 weeks gestationRate of Adverse reaction such as Vomiting, nausea, constipation, diarrhea or allergy
Correction rate of ferritin deficiency37-41 weeks gestationCorrection rate of ferritin deficiency
reticulocyte count20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestationreticulocyte count in whole blood
ferritin20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestationConcentration of ferritin value in serum

Countries

China

Contacts

Primary ContactZhang Zhiwei, PH.D
zzw_sun@163.com13953109309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026