Iron Deficiency Anemia of PregnancyPhase 4NCT05804071
Analysis of the Effect of Iron Supplements on Iron Deficiency Anemia in Pregnancy
A Phase 4 study testing Niferex in people with Iron Deficiency Anemia of Pregnancy and Iron Storage Disease, run by Qianfoshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy, Iron Storage Disease
- What is being tested?
- Niferex
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
Shandong PQ Hospital, Ph.D, 13953109309, zzw_sun@163.com
About this study
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
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.
Read the 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
- Being tested
- Niferex
- Medical subject headings
- Hemochromatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiferexDrug
Also called MonoFer
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
| Study group | Role | What they receive |
|---|---|---|
| 150mg QD | Active comparator | Each subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every day. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Niferex |
| Intravenous iron supplement | Active comparator | Each subject was given intravenous iron supplements according to the instructions Receives: Drug: Niferex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin
Concentration of Ferritin in serum in late pregnancy
Measured: 37-41 weeks gestation
Elevated hemoglobin value
Elevated hemoglobin value between 24 and 41 weeks of gestation
Measured: 37-41 weeks gestation
Secondary outcomes (9)
Hemoglobin
Concentration of Hemoglobin value in whole blood
Measured: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
ferritin
Concentration of ferritin value in serum
Measured: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
serum iron
Concentration of serum iron value in serum
Measured: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
transferrin saturation
Concentration of transferrin saturation value in serum
Measured: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
total iron binding force
total iron binding force in serum
Measured: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
reticulocyte count
reticulocyte count in whole blood
Measured: 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
Measured: 37-41 weeks gestation
Adverse reaction rate
Rate of Adverse reaction such as Vomiting, nausea, constipation, diarrhea or allergy
Measured: 37-41 weeks gestation
Correction rate of ferritin deficiency
Correction rate of ferritin deficiency
Measured: 37-41 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start28 Mar 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia of PregnancyStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Zhiwei, PH.D, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804071
- Sponsor's protocol ID
- YXL-KY-2023（006）
- Status last verified
- Apr 2023
- First submitted
- 2 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05804071
- Acronym / sponsor ID
- YXL-KY-2023（006）
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 150mg QD | Active comparator | Drug: NiferexEach subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every day. |
| 150mg QOD | Active comparator | Drug: NiferexEach subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every other day. |
| 300mg QD | Active comparator | Drug: NiferexEach subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every day. |
| 300mg QOD | Active comparator | Drug: NiferexEach subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every other day. |
| Intravenous iron supplement | Active comparator | Drug: NiferexEach subject was given intravenous iron supplements according to the instructions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiferexAlso: MonoFerDaily 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 | Drug | 150mg QD, 150mg QOD, 300mg QD, 300mg QOD, Intravenous iron supplement |
Primary outcome
Ferritin
Time frame: 37-41 weeks gestation
Concentration of Ferritin in serum in late pregnancy
Elevated hemoglobin value
Time frame: 37-41 weeks gestation
Elevated hemoglobin value between 24 and 41 weeks of gestation
9 secondary outcomes
Hemoglobin
Time frame: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
ferritin
Time frame: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
serum iron
Time frame: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
transferrin saturation
Time frame: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
total iron binding force
Time frame: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
reticulocyte count
Time frame: 20-24 weeks gestation，30-32 weeks gestation，37-41 weeks gestation
Correction rate of iron deficiency anemia during pregnancy
Time frame: 37-41 weeks gestation
Adverse reaction rate
Time frame: 37-41 weeks gestation
Correction rate of ferritin deficiency
Time frame: 37-41 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Zhiwei, PH.D study chair
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Niferex in people with Iron Deficiency Anemia of Pregnancy and Iron Storage Disease, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Zhiwei, PH.D (13953109309, zzw_sun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferritin (time frame: 37-41 weeks gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.