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Iron Deficiency Anemia of PregnancyNCT05151679

Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy

A study testing Chelated Iron and Iron sucrose in people with Iron Deficiency Anemia of Pregnancy, run by Assiut University.

Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

compare the efficacy and safety of intravenous iron sucrose versus chelated oral iron in the treatment of iron deficiency anemia late in pregnancy. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Iron Deficiency Anemia of Pregnancy
What is being tested?
Chelated Iron and Iron sucrose
How many people
Not given
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Expanded access
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women aged 18 years or more with established iron deficiency anemia ( Hb: 8-10 )
  • Pregnancy 26-34 weeks

Who cannot join

  • Anemia due to other causes than iron deficiency anemia.
  • Recent blood transfusion (in the last 3 months ).
  • Allergy to iron.
  • Multiple pregnancy.

Trial locations and contacts

No sites are listed yet.

mahmoud farghaly, resident contact

+201005450572

mahmoudshaban8.ms@gmail.com

mohammed sayed, prof contact

+201006801036

Msayed21@yahoo.com

About this study

Official title: Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy ( Randomized Controlled Trial )

compare the efficacy and safety of intravenous iron sucrose versus chelated oral iron in the treatment of iron deficiency anemia late in pregnancy.

Read the detailed description

patients will be recruited from the pregnant women who will attend the outpatient clinic at Women's Health Hospital Assuit University with the diagnosis of iron deficiency anaemia between 26-34 weeks with Hb level 8-10 in the initial visit the patients will be counselled about the iron therapy, its benefits and risk of discontinuation written consent will be obtained.

All women will be subjected to the following:

  1. History taking
  2. Personal history: demographic factors, age and dietary habits.
  3. Obstetric history: parity, EDD, last delivery, gestational age determined from last menstrual period or previous early ultrasound scanning report.
  4. Past history: history of chronic diseases such as diabetes or hypertension, blood transfusion and either oral or i.v iron treatment.
  5. Clinical examination General examination including pulse, blood pressure, BMI, pallor, temperature and auscultation of lungs and heart. Abdominal examination for fundal level. The patients of the study will be randomly divided into two groups Group 1 will be treated by I.V ferrous sucrose Group 2 will be treated by chelated oral iron
  6. Invetigations
  • Ultrasonography in the initial visit to assess fetal well being.
  • Blood sample will be taken at recruitment on day 0, day 14, day 28, day 40 of therapy.these time points were chosen on the basis of previous studies and to minimize inconvenience to women. The time points were also chosen to detect any difference in the speed of restoration of Hb% and iron stores. The blood sample will be examined for the following:
  1. Complete blood picture. A sample of 2 ml venous blood will be collected in EDTA vacutainers.
  2. Serum ferritin evaluation. A sample of 2 ml venous blood will be collected in EDTA vacutainers and separated sera will be stored at 20 C until the time of assay by turbidimetric technique.
  3. Total iron binding capacity. A sample of 2 ml venous blood will be collected in EDTA vacutainers
  4. Doses and administration Treatment will be started 24rh after initial visit women will be randomized used random sequence computer generated list in such a way that every patient had equal chance to be among any of the two groups either to group 1 , where they will receive I.V ferrous sucrose in the E.U in Women's Health Hospital Assuit University as an i.v infusion in 250 ml 0.9% sodium chloride slowly over 30 minutes, and then will be discontinued for another 30 minutes to detect any hypersensitivity reactions with monitoring of vital signs during infusion, antishock measures will be prepared beside the patient during administration ( corticosteroids, antihistaminic, calcium and oxygen ). Patients will be asked to note any symptoms or adverse effects of treatment such as facial flushing nausea, metallic taste, dyspepsia, and burning at the site of injection.

The dose in mg will be calculated from the following formula:

2.4 × weight × ( target - actual Hb ) I g/dl + 500 Target Hb 12 g% The total required dose of iron will be divided into three doses, which will be given every 3 days, and the maximum daily dose is 200mg ( 2 ampoules ). This group will not receive further iron supplementation. They will be asked to note any symptoms or adverse effects of treatment.

or to group 2 where they will receive chelated oral iron, they will be given iron chelated amino acid containing 15 mg of elemental iron once daily for 6 weeks. the women will be advised to take 1 tab of iron chelated amino acid containing 15mg of elemental iron once daily with meals for 6 weeks from the day of recruitment. Date will be given when to stop oral supplementation after 6 weeks. This group will be advised to note side effects such as nausea, metallic taste, dyspepsia and constipation.

We will add 500µg of folic acid to patients of group 1 once daily for 6 weeks to eliminate the differences in the results between the groups as ferrotron ( chelated oral iron for second group ) contains 400µg folic acid.

Being tested
Chelated Iron, Iron sucrose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chelated IronDrug

    Also called ferrotron

    Treatment will be started 24rh after initial visit women will be randomized used random sequence computer generated list in such a way that every patient had equal chance to be among any of the two groups either to group 1 , where they will receive I.V ferrous sucrose in the E.U in Women's Health Hospital Assuit University as an i.v infusion in 250 ml 0.9% sodium chloride slowly over 30 minutes.

    The total required dose of iron will be divided into three doses, which will be given every 3 days, and the maximum daily dose is 200mg ( 2 ampoules ).

  • Iron sucroseDrug

    Also called sacrofer

    to group 2 where they will receive chelated oral iron, they will be given iron chelated amino acid containing 15 mg of elemental iron once daily for 6 weeks. the women will be advised to take 1 tab of iron chelated amino acid containing 15mg of elemental iron once daily with meals for 6 weeks from the day of recruitment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT05151679
Sponsor's protocol ID
oral iron versus I.V iron
Status last verified
Nov 2021
First submitted
28 Nov 2021
Last updated
9 Dec 2021
Results posted
No

Publications

  • Bencaiova G, von Mandach U, Zimmermann R. Iron prophylaxis in pregnancy: intravenous route versus oral route. Eur J Obstet Gynecol Reprod Biol. 2009 Jun;144(2):135-9. doi: 10.1016/j.ejogrb.2009.03.006. Epub 2009 Apr 29.

    PubMed 19406557
  • Means RT. Iron Deficiency and Iron Deficiency Anemia: Implications and Impact in Pregnancy, Fetal Development, and Early Childhood Parameters. Nutrients. 2020 Feb 11;12(2):447. doi: 10.3390/nu12020447.

    PubMed 32053933

Questions about this trial

What is this clinical trial studying?

A study testing Chelated Iron and Iron sucrose in people with Iron Deficiency Anemia of Pregnancy, run by Assiut University.

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 2 inclusion and 4 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact mahmoud farghaly, resident (+201005450572, mahmoudshaban8.ms@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05151679, which also lists 2 linked publications.

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 9 Dec 2021.

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