Iron Deficiency AnemiaPhase 1/2TDINCT03279536
Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing
A Phase 1/2 study testing Oral lactoferrin and TDI of LMW iron dextran in people with Iron Deficiency Anemia, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without health education and another 30 were given iron supplementation and health education for comparison between them. 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?
- Oral lactoferrin and TDI of LMW 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
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 30 Dec 2018
- Phase
- Phase 1/2
- 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 aged >18 years
- Hemoglobin<10g/dl
- Gestational age between 14-28 weeks
- Singleton pregnancy
- Willingness to participate and signing the informed consent form
Who cannot join
- Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12 or foliate deficiency, hemolytic anemia),
- Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and haemosidrosis).
- Decompensated liver cirrhosis and active hepatitis (ALAT>3 times upper limit of normal).
- Active acute or chronic infections (assessed by clinical judgment supplied with white Blood Cells (WBC) and C - reactive protein (CRP).
- Rheumatoid arthritis with symptoms or signs of active inflammation.
- Multiple allergies.
Show all 12Show fewer
- Known hypersensitivity to parental iron or any recipients in the investigational drug products.
- Erythropoietin treatment within 8 weeks prior to the screening visit.
- Other iron treatment within 8 weeks prior to the screening visit.
- Planned elective surgery during the study.
- Participation in any other clinical within 3 months prior to the screening.
- Any other medical condition e.g. malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without health education and another 30 were given iron supplementation and health education for comparison between them. Comparative between hemoglobin levels before and after medication. Treatment of iron deficiency anemia with iron supplementation received for one month.
Read the detailed description
The investigator will divide the participants into two groups e.g. group (A) and group (B) according to Hemoglobin level and receiving of oral supplementation for IDA accompanied with health education in case of group (A) and without health education in case of group (B). Then the investigator asked patient to sign the document of her investigations result to receive iron supplementation.
- After that, the investigator observes hemoglobin's Level, when it less than >11g/dl, the patient will be the group (A) who will receive oral iron supplementation and health education.
- Group (B) who will receive Total Dose Infusion (TDI) without health education.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Oral lactoferrin, TDI of LMW iron dextran
- 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.
Oral lactoferrinCombination product
Also called Oral Fizzing Lactoferrin
Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.
TDI of LMW iron dextranCombination product
Also called Parental dextran
Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously
| Study group | Role | What they receive |
|---|---|---|
| Oral Lactoferrin | Experimental | Group A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks Receives: Combination Product: Oral lactoferrin |
| Total dose infusion (TDI) iron dextran | Active comparator | Group B is a parenteral total dose infusion (TDI) of LMW iron dextran 20mg/kg body weight for 4 weeks Intervention: The participants 33 will receive parental iron 20mg/kg body weight for 4 weeks Receives: Combination Product: TDI of LMW iron dextran |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in Hb concentration
measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia
Measured: 4- 8 weeks
Secondary outcomes (1)
measure the change in serum iron, serum ferritin
measure the change in serum iron, serum ferritin based on comparison between oral lactoferrin with health education \& TDI from hospital routine care.
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Nov 2017
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will receive oral lactoferrin \& group B will receive Total dose infusion
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howieda Fouly, Woman's Health University Hospital, Egypt
- Investigators
- Warda Helmy, BSN, Principal investigator, WHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279536
- Sponsor's protocol ID
- WHH
- Acronym
- TDI
- Status last verified
- Oct 2020
- First submitted
- 30 Aug 2017
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publishing
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing
- ClinicalTrials.gov ID
- NCT03279536
- Acronym / sponsor ID
- TDI / WHH
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 12 Sep 2017 (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.
This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without health education and another 30 were given iron supplementation and health education for comparison between them. Comparative between hemoglobin levels before and after medication. Treatment of iron deficiency anemia with iron supplementation received for one month.
Detailed description
The investigator will divide the participants into two groups e.g. group (A) and group (B) according to Hemoglobin level and receiving of oral supplementation for IDA accompanied with health education in case of group (A) and without health education in case of group (B). Then the investigator asked patient to sign the document of her investigations result to receive iron supplementation.
- After that, the investigator observes hemoglobin's Level, when it less than >11g/dl, the patient will be the group (A) who will receive oral iron supplementation and health education.
- Group (B) who will receive Total Dose Infusion (TDI) without health education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group A will receive oral lactoferrin \& group B will receive Total dose infusion
| Arm | Type | Receives |
|---|---|---|
| Oral Lactoferrin | Experimental | Combination Product: Oral lactoferrinGroup A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks |
| Total dose infusion (TDI) iron dextran | Active comparator | Combination Product: TDI of LMW iron dextranGroup B is a parenteral total dose infusion (TDI) of LMW iron dextran 20mg/kg body weight for 4 weeks Intervention: The participants 33 will receive parental iron 20mg/kg body weight for 4 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant Women aged >18 years
- Hemoglobin<10g/dl
- Gestational age between 14-28 weeks
- Singleton pregnancy
- Willingness to participate and signing the informed consent form
Key exclusion criteria (12 listed)
- Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12 or foliate deficiency, hemolytic anemia),
- Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and haemosidrosis).
- Decompensated liver cirrhosis and active hepatitis (ALAT>3 times upper limit of normal).
- Active acute or chronic infections (assessed by clinical judgment supplied with white Blood Cells (WBC) and C - reactive protein (CRP).
- Rheumatoid arthritis with symptoms or signs of active inflammation.
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 |
|---|---|---|
| Oral lactoferrinAlso: Oral Fizzing LactoferrinOral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste. | Combination product | Oral Lactoferrin |
| TDI of LMW iron dextranAlso: Parental dextranTotal Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously | Combination product | Total dose infusion (TDI) iron dextran |
Primary outcome
the change in Hb concentration
Time frame: 4- 8 weeks
measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia
1 secondary outcome
measure the change in serum iron, serum ferritin
Time frame: 4-8 weeks
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 27 Oct 2020.
- Individual participant dataSharing planned: Yes. Publishing
Related trials for Iron Deficiency Anemia
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
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.
Warda Helmy, BSN principal investigator
WHH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral lactoferrin and TDI of LMW iron dextran in people with Iron Deficiency Anemia, run by Woman's Health University Hospital, Egypt 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 5 inclusion and 12 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 27 Oct 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 change in Hb concentration (time frame: 4- 8 weeks). 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 27 Oct 2020; AzTrials last refreshed its copy on 1 Nov 2026.