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

NCT05804071 | Unknown Phase 4

• 1 other identifier: YXL-KY-2023（006）
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia of Pregnancy; Iron Storage Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Hemoglobin

  20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation

• ferritin

  20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation

• serum iron

  20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation

• transferrin saturation

  20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation

• total iron binding force

  20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation

Study Arms (5)

150mg QD

ACTIVE COMPARATOR

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

Drug: Niferex

150mg QOD

ACTIVE COMPARATOR

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

Drug: Niferex

300mg QD

ACTIVE COMPARATOR

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

Drug: Niferex

300mg QOD

ACTIVE COMPARATOR

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

Drug: Niferex

Intravenous iron supplement

ACTIVE COMPARATOR

Each subject was given intravenous iron supplements according to the instructions

Drug: Niferex

Interventions

Niferex DRUG

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

Also known as: MonoFer

150mg QD; 150mg QOD; 300mg QD; 300mg QOD; Intravenous iron supplement

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women of childbearing age who can be pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Hemochromatosis

Interventions

Niferex

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Overload; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zhang Zhiwei, PH.D

  Qianfoshan Hospital

  STUDY CHAIR

Central Study Contacts

Zhang Zhiwei, PH.D

CONTACT

13953109309; zzw_sun@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 7, 2023
• Study Start: March 28, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

CN (1)