Anemia of PregnancyNCT04101461
The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant
A study testing Iron, Complete blood count and Serum ferritin in people with Anemia of Pregnancy, run by Assiut University at 1 site in Egypt.
Trial summary
Anemia is known as a condition in which the hemoglobin level is lower than normal. Anemia is one of the most common complications during pregnancy. Anemia in pregnancy is defined as a hemoglobin level < 110 g/L . Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Anemia of Pregnancy
- What is being tested?
- Iron, Complete blood count and Serum ferritin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Apr 2022
- Phase
- Interventional
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman in a singleton pregnancy (12-14 weeks).
- BMI (30- 40 kg/m2).
- Normal hemoglobin level (>11 g/dL).
- Normal hematocrit (Hct 31-41%).
- Normal ferritin level (6-130 ng/mL).
- Women willingness to participate in the study.
- Women living in the nearby area to make follow-up visits possible.
Who cannot join
- Multiple gestations.
- Women received a recent blood transfusion.
- Women with threatened miscarriage.
- Women are known to have pathological blood loss.
- Intolerant to oral iron form.
- History of the hematologic disorder.
- Women used iron in the past 3 months.
- Women with chronic diseases (hypertension, diabetes, renal diseases, thyroid disease……).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Single Versus Double Daily Dose of Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant Women
Anemia is known as a condition in which the hemoglobin level is lower than normal. Anemia is one of the most common complications during pregnancy. Anemia in pregnancy is defined as a hemoglobin level < 110 g/L . Anemia is an important risk factor in pregnancy which leads to both maternal and fetal morbidity and mortality.
The pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common during pregnancy. In Egypt; iron deficiency anemia affects about one in every two pregnant women, especially in rural areas. Pregnant women require about 27 mg/day elemental iron to cover their increased need. The pregnant women should start taking a daily supplement of 30mg of elemental iron as a preventive measure against iron deficiency anemia especially in poor countries.
Read more
Obesity is defined as having an excessive amount of body fat. The body mass index, a measurement based on height and weight, determines the obese if the figure more than 30 kg/m2. There is an increased rate of overweight and obesity among pregnant women. According to the World Health Organization, 46% of adult females in Egypt are obese.
Many researches in the literature revealed a strong relationship between high BMI in pregnancy and iron deficiency anemia. Hepcidin is an iron regulating hormone in the body. Increases in iron levels in the plasma stimulate the production of hepcidin, which blocks iron absorption from the diet, so; hepcidin production is suppressed in the case of iron deficiency.
- Conditions
- Anemia of Pregnancy
- Being tested
- Iron, Complete blood count, Serum ferritin, Serum hepcidin, Serum Iron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IronDrug
PharaFerro27; Devart Lab Company, Egypt
Complete blood countDiagnostic test
to assess the anemia
Serum ferritinDiagnostic test
to assess the anemia
Serum hepcidinDiagnostic test
to assess the iron abosrption
Serum IronDiagnostic test
to assess the anemia
Serum total iron binding capacityDiagnostic test
to assess the anemia
| Study group | Role | What they receive |
|---|---|---|
| Group I: 27 mg elemental iron | Active comparator | will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks Receives: Drug: Iron; Diagnostic Test: Complete blood count; Diagnostic Test: Serum ferritin; Diagnostic Test: Serum hepcidin; Diagnostic Test: Serum Iron; Diagnostic Test: Serum total iron binding capacity |
| Group II: 54 mg elemental iron | Active comparator | will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks Receives: Drug: Iron; Diagnostic Test: Complete blood count; Diagnostic Test: Serum ferritin; Diagnostic Test: Serum hepcidin; Diagnostic Test: Serum Iron; Diagnostic Test: Serum total iron binding capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of anemic women at time of delivery
Measured: 6 months
Secondary outcomes (4)
The mean level of maternal Hemoglobin at 37-38 weeks .
Measured: 6 months
The incidence of patients' reported side effect
Measured: 6 months
The difference in serum ferritin
Measured: 6 months
The difference in serum hepcidin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101461
- Sponsor's protocol ID
- IDA-Obese
- Status last verified
- May 2022
- First submitted
- 22 Sep 2019
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Single Versus Double Daily Dose of Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT04101461
- Acronym / sponsor ID
- IDA-Obese
- Conditions
- Anemia of Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 24 Sep 2019 (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.
Anemia is known as a condition in which the hemoglobin level is lower than normal. Anemia is one of the most common complications during pregnancy. Anemia in pregnancy is defined as a hemoglobin level < 110 g/L . Anemia is an important risk factor in pregnancy which leads to both maternal and fetal morbidity and mortality.
The pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common during pregnancy. In Egypt; iron deficiency anemia affects about one in every two pregnant women, especially in rural areas. Pregnant women require about 27 mg/day elemental iron to cover their increased need. The pregnant women should start taking a daily supplement of 30mg of elemental iron as a preventive measure against iron deficiency anemia especially in poor countries.
Obesity is defined as having an excessive amount of body fat. The body mass index, a measurement based on height and weight, determines the obese if the figure more than 30 kg/m2. There is an increased rate of overweight and obesity among pregnant women. According to the World Health Organization, 46% of adult females in Egypt are obese.
Many researches in the literature revealed a strong relationship between high BMI in pregnancy and iron deficiency anemia. Hepcidin is an iron regulating hormone in the body. Increases in iron levels in the plasma stimulate the production of hepcidin, which blocks iron absorption from the diet, so; hepcidin production is suppressed in the case of iron deficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: 27 mg elemental iron | Active comparator | Drug: Iron, Diagnostic Test: Complete blood count, Diagnostic Test: Serum ferritin, Diagnostic Test: Serum hepcidin, Diagnostic Test: Serum Iron, Diagnostic Test: Serum total iron binding capacitywill receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks |
| Group II: 54 mg elemental iron | Active comparator | Drug: Iron, Diagnostic Test: Complete blood count, Diagnostic Test: Serum ferritin, Diagnostic Test: Serum hepcidin, Diagnostic Test: Serum Iron, Diagnostic Test: Serum total iron binding capacitywill receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant woman in a singleton pregnancy (12-14 weeks).
- BMI (30- 40 kg/m2).
- Normal hemoglobin level (>11 g/dL).
- Normal hematocrit (Hct 31-41%).
- Normal ferritin level (6-130 ng/mL).
Key exclusion criteria (8 listed)
- Multiple gestations.
- Women received a recent blood transfusion.
- Women with threatened miscarriage.
- Women are known to have pathological blood loss.
- Intolerant to oral iron form.
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 |
|---|---|---|
| IronPharaFerro27; Devart Lab Company, Egypt | Drug | Group I: 27 mg elemental iron, Group II: 54 mg elemental iron |
| Complete blood countto assess the anemia | Diagnostic test | Group I: 27 mg elemental iron, Group II: 54 mg elemental iron |
| Serum ferritinto assess the anemia | Diagnostic test | Group I: 27 mg elemental iron, Group II: 54 mg elemental iron |
| Serum hepcidinto assess the iron abosrption | Diagnostic test | Group I: 27 mg elemental iron, Group II: 54 mg elemental iron |
| Serum Ironto assess the anemia | Diagnostic test | Group I: 27 mg elemental iron, Group II: 54 mg elemental iron |
| Serum total iron binding capacityto assess the anemia | Diagnostic test | Group I: 27 mg elemental iron, Group II: 54 mg elemental iron |
Primary outcome
The number of anemic women at time of delivery
Time frame: 6 months
4 secondary outcomes
The mean level of maternal Hemoglobin at 37-38 weeks .
Time frame: 6 months
The incidence of patients' reported side effect
Time frame: 6 months
The difference in serum ferritin
Time frame: 6 months
The difference in serum hepcidin
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Anemia of Pregnancy
RecruitingPhase 2
Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females
Iron Deficiency (ID), Pregnancy
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruitingPhase 1
Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
Chronic Kidney Disease, Anemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron, Complete blood count and Serum ferritin in people with Anemia of Pregnancy, run by Assiut University at 1 site in Egypt.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 4 May 2022. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of anemic women at time of delivery (time frame: 6 months). 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 4 May 2022.