Treatment of Iron Deficiency Anemia in PregnancyPhase 4NCT02086838
Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
A Phase 4 study testing Theragran Hematinic and low molecular weight iron dextran in people with Treatment of Iron Deficiency Anemia in Pregnancy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Evaluate the effect of iron supplementation using oral routes in comparison with total dose infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Treatment of Iron Deficiency Anemia in Pregnancy
- What is being tested?
- Theragran Hematinic and low molecular weight iron dextran
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2013to Dec 2014
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age 20-35 years old.
- Singleton pregnancy between 16 - 24 weeks.
- Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study.
Who cannot join
- Extremes of reproductive age (less than 20 years old or more than 35 years old).
- Patients with multiple pregnancies.
- Anemia not linked to iron deficiency.
- Allergy to iron derivatives.
- Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
- Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
- Any obstetric complicating factors like pregnancy induced hypertension.
- Patients with history of chronic blood loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
Evaluate the effect of iron supplementation using oral routes in comparison with total dose infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.
Read the detailed description
Patients will be allocated to two groups of 106 each and to insure that everyone has the chance of participation, randomization will be guided by table of random numbers All women recruited in the study will be given 100 mg mebendazole tablets twice daily for 3 days for de-worming and 500 micro gram folic acid daily till the end of the study The required dose will be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status Total iron dose (mg) = weight (kg) X hemoglobin deficit {target hemoglobin (g/l)- Actual hemoglobin (g/l)} X 0.24 + 500 mg The total iron dose needed will be calculated by formula rounded to nearest multiple of 100 Group I includes pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® Smith-Kline Beecham, Egypt an affiliated co. to Glaxo Smith-Kline, according to the WHO guidelines for IDA control Group II includes pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R Pharmacosmos Denmark (Inspire Pharma Egypt) Inclusion criteria
- Maternal age 20-35 years old.
- Singleton pregnancy between 16 - 24 weeks
- Iron deficiency anemia with average hemoglobin ranging from 7-9 g/dL at the onset of the study
Exclusion criteris
- Extremes of reproductive age (less than 20 years old or more than 35 years old).
- Patients with multiple pregnancies.
- Anemia not linked to iron deficiency.
- Allergy to iron derivatives.
- Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
- Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
- Any obstetric complicating factors like pregnancy induced hypertension (PIH).
- Patients with history of chronic blood loss.
- Being tested
- Theragran Hematinic, low molecular weight iron dextran
- Keywords
- Iron deficiency anemia, Pregnancy, Iron therapy
- 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.
Theragran HematinicDrug
low molecular weight iron dextranDrug
Also called Cosmofer
| Study group | Role | What they receive |
|---|---|---|
| Theragran Hematinic, oral iron, 120 mg elemental iron/ | Active comparator | pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® SmithKline Beecham, Egypt an affiliated co. to GlaxoSmithKline. Adherence to the treatment will be monitored by asking the women to bring back the empty packs and mark the consumption of tablets on calendar. Receives: Drug: Theragran Hematinic |
| low molecular weight iron dextran, total dose infusion | Active comparator | Pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R pharmacosmos Denmark (Inspire Pharma Egypt). Patients selected for parental iron will be admitted as day cases in the hospital in a single visit. The required dose has to be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status. Total iron dose (mg) = weight (kg) X Hemoglobin deficit {target Hemoglobin (g/l)- Actual Hemoglobin (g/l)} X 0.24 + 500 mg. Receives: Drug: low molecular weight iron dextran |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who have been successfully treated
The proportion of patients who have been successfully treated as evidenced by a hemoglobin concentration of > 10.5 g% after 8 weeks from completing treatment (oral or total iron dose infusion therapy).
Measured: up to 8 weeks from comleting treatment
Secondary outcomes (1)
Number of participants with adverse effects
Measured: up to 8 weeks after completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Iron Deficiency Anemia in PregnancyStudies 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
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
- Investigators
- Mohamed S. Sweed, MD, Principal investigator, AinShams UniversityHazem M. Sammour, Professor, Study director, AinShams UniversityAbdel-Latif G. El-Kholy, Ass. Prof., Principal investigator, AinShams UniversityEman M. El-Garhi, M.B.B.Ch., Principal investigator, El Galaa Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086838
- Sponsor's protocol ID
- 9020058
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
- ClinicalTrials.gov ID
- NCT02086838
- Acronym / sponsor ID
- 9020058
- Keywords
- Iron deficiency anemia, Pregnancy, Iron therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Mar 2014 (estimated)
- 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.
Evaluate the effect of iron supplementation using oral routes in comparison with total dose infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.
Detailed description
Patients will be allocated to two groups of 106 each and to insure that everyone has the chance of participation, randomization will be guided by table of random numbers All women recruited in the study will be given 100 mg mebendazole tablets twice daily for 3 days for de-worming and 500 micro gram folic acid daily till the end of the study The required dose will be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status Total iron dose (mg) = weight (kg) X hemoglobin deficit {target hemoglobin (g/l)- Actual hemoglobin (g/l)} X 0.24 + 500 mg The total iron dose needed will be calculated by formula rounded to nearest multiple of 100 Group I includes pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® Smith-Kline Beecham, Egypt an affiliated co. to Glaxo Smith-Kline, according to the WHO guidelines for IDA control Group II includes pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R Pharmacosmos Denmark (Inspire Pharma Egypt) Inclusion criteria
- Maternal age 20-35 years old.
- Singleton pregnancy between 16 - 24 weeks
- Iron deficiency anemia with average hemoglobin ranging from 7-9 g/dL at the onset of the study
Exclusion criteris
- Extremes of reproductive age (less than 20 years old or more than 35 years old).
- Patients with multiple pregnancies.
- Anemia not linked to iron deficiency.
- Allergy to iron derivatives.
- Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
- Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
- Any obstetric complicating factors like pregnancy induced hypertension (PIH).
- Patients with history of chronic blood loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theragran Hematinic, oral iron, 120 mg elemental iron/ | Active comparator | Drug: Theragran Hematinicpregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® SmithKline Beecham, Egypt an affiliated co. to GlaxoSmithKline. Adherence to the treatment will be monitored by asking the women to bring back the empty packs and mark the consumption of tablets on calendar. |
| low molecular weight iron dextran, total dose infusion | Active comparator | Drug: low molecular weight iron dextranPregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R pharmacosmos Denmark (Inspire Pharma Egypt). Patients selected for parental iron will be admitted as day cases in the hospital in a single visit. The required dose has to be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status. Total iron dose (mg) = weight (kg) X Hemoglobin deficit {target Hemoglobin (g/l)- Actual Hemoglobin (g/l)} X 0.24 + 500 mg. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Maternal age 20-35 years old.
- Singleton pregnancy between 16 - 24 weeks.
- Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study.
Key exclusion criteria (8 listed)
- Extremes of reproductive age (less than 20 years old or more than 35 years old).
- Patients with multiple pregnancies.
- Anemia not linked to iron deficiency.
- Allergy to iron derivatives.
- Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
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 |
|---|---|---|
| Theragran Hematinic | Drug | Theragran Hematinic, oral iron, 120 mg elemental iron/ |
| low molecular weight iron dextranAlso: Cosmofer | Drug | low molecular weight iron dextran, total dose infusion |
Primary outcome
The proportion of patients who have been successfully treated
Time frame: up to 8 weeks from comleting treatment
The proportion of patients who have been successfully treated as evidenced by a hemoglobin concentration of > 10.5 g% after 8 weeks from completing treatment (oral or total iron dose infusion therapy).
1 secondary outcome
Number of participants with adverse effects
Time frame: up to 8 weeks after completing treatment
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 19 Mar 2015.
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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.
Mohamed S. Sweed, MD principal investigator
AinShams University
Hazem M. Sammour, Professor study director
AinShams University
Abdel-Latif G. El-Kholy, Ass. Prof. principal investigator
AinShams 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 Theragran Hematinic and low molecular weight iron dextran in people with Treatment of Iron Deficiency Anemia in Pregnancy, 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 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 19 Mar 2015. 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?
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 proportion of patients who have been successfully treated (time frame: up to 8 weeks from comleting 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 19 Mar 2015.