Iron Deficiency AnemiaPhase 4NCT03830034
Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
A Phase 4 study testing Amino Acid chelated iron tab 15 mg and Ferrous Fumarate tab 350 mg( 115 mg elemental iron) in people with Iron Deficiency Anemia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Amino Acid chelated iron tab 15 mg and Ferrous Fumarate tab 350 mg( 115 mg elemental iron)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2019to 1 Dec 2019
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound
- Hemoglobin level 8-10.5 g/dL
- Serum ferritin<15µg/L
Who cannot join
- The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency anemia,Vitamin B12 deficiency, ect…).
- Multiple gestations
- The presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease
- Patients with known gastritis
- History of mal-absorption syndrome
- Those with known hypersensitivity to iron preparations
- Those under current iron supplementation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university maternity hospital
Cairo, 25187
Ahmed A Elshahawy, MD, +201223266380, ahmedshafy@hotmail.com
About this study
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).
Read the detailed description
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).
- Conditions
- Iron Deficiency Anemia
- Being tested
- Amino Acid chelated iron tab 15 mg, Ferrous Fumarate tab 350 mg( 115 mg elemental iron)
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid chelated iron tab 15 mgDrug
Also called Ferrotron
Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) a dose recommended by the company of the product.
Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.
Substances that inhibit absorption such as tannins \& milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.
Follow up will be done for all the pregnant women included in our studies at baseline \& then 4, 8 \& 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.
Ferrous Fumarate tab 350 mg( 115 mg elemental iron)Drug
Also called Haemacaps
75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb<9g/dl) this dose can be doubled as recommended by the company of the product.
Some instructions will be given to all the pregnant women included in our study as follow: Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.
Substances that inhibit absorption such as tannins \& milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.
Follow up will be done for all the pregnant women included in our studies at baseline \& then 4, 8 \& 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid chelated iron tab 15 mg group | Experimental | Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) prepared by egyptian pharmaceutical company (nerhadou) once daily (a dose recommended by the company of the product). Receives: Drug: Amino Acid chelated iron tab 15 mg |
| Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group | Active comparator | Contain 75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb<9g/dl) this dose can be doubled as recommended by the company of the product. Receives: Drug: Ferrous Fumarate tab 350 mg( 115 mg elemental iron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobine (Hb) Rise
follow up CBC after 12 weeks of treatment given
Measured: after 12 weeks of treatment.
Secondary outcomes (2)
Hemoglobine (Hb) Rise
Follow up CBC after 4,8 weeks of treatment given
Measured: after 4,8 weeks of treatment.
Adverse effects of the medication given
constipation, nausea, allergy.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start2 Feb 2019
- Primary completion15 Oct 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Shafy El Shahawy, Ain Shams University
- Investigators
- Ahmed Elshahawy, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830034
- Sponsor's protocol ID
- IDA
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03830034
- Acronym / sponsor ID
- IDA
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 5 Feb 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 the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).
Detailed description
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino Acid chelated iron tab 15 mg group | Experimental | Drug: Amino Acid chelated iron tab 15 mgContain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) prepared by egyptian pharmaceutical company (nerhadou) once daily (a dose recommended by the company of the product). |
| Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group | Active comparator | Drug: Ferrous Fumarate tab 350 mg( 115 mg elemental iron)Contain 75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb<9g/dl) this dose can be doubled as recommended by the company of the product. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound
- Hemoglobin level 8-10.5 g/dL
- Serum ferritin<15µg/L
Key exclusion criteria (7 listed)
- The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency anemia,Vitamin B12 deficiency, ect…).
- Multiple gestations
- The presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease
- Patients with known gastritis
- History of mal-absorption syndrome
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 |
|---|---|---|
| Amino Acid chelated iron tab 15 mgAlso: FerrotronContain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) a dose recommended by the company of the product. Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption. Substances that inhibit absorption such as tannins \& milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption. Follow up will be done for all the pregnant women included in our studies at baseline \& then 4, 8 \& 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed. | Drug | Amino Acid chelated iron tab 15 mg group |
| Ferrous Fumarate tab 350 mg( 115 mg elemental iron)Also: Haemacaps75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb<9g/dl) this dose can be doubled as recommended by the company of the product. Some instructions will be given to all the pregnant women included in our study as follow: Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption. Substances that inhibit absorption such as tannins \& milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption. Follow up will be done for all the pregnant women included in our studies at baseline \& then 4, 8 \& 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed. | Drug | Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group |
Primary outcome
Hemoglobine (Hb) Rise
Time frame: after 12 weeks of treatment.
follow up CBC after 12 weeks of treatment given
2 secondary outcomes
Hemoglobine (Hb) Rise
Time frame: after 4,8 weeks of treatment.
Adverse effects of the medication given
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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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.
Ahmed Elshahawy, MD principal investigator
Ain Shams University
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 Amino Acid chelated iron tab 15 mg and Ferrous Fumarate tab 350 mg( 115 mg elemental iron) in people with Iron Deficiency Anemia, run by Ain Shams 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 3 inclusion and 7 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 5 Feb 2019. 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.
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 Ahmed Elshahawy, MD (+01223266380, ahmedshafy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobine (Hb) Rise (time frame: after 12 weeks of treatment.). 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 5 Feb 2019.