Iron Deficiency Anemia of PregnancyLactoferrinNCT03456258
Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy
A study testing Complete blood count in people with Iron Deficiency Anemia of Pregnancy, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Complete blood count
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2017to 15 Jan 2018
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women from 20 to 40 years
- iron deficiency anemia (mild and moderate)
- gestational age 13 to 26 weeks
- singleton viable pregnancy.
Who cannot join
- history of anemia due to chronic blood loss
- hemolytic anemia
- severe anemia
- history of peptic ulcer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy,a Randomized Clinical Trial
The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.
Read the detailed description
The study was done at ainshams university maternity hospital on 100 pregnant women randomized in two groups .
Group one lactoferrin group Group two ferrous sulphate group
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- Complete blood count
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood countDiagnostic test
Also called Serum ferritin
To measure hemoglobin difference and serum ferritin levels .
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin | Experimental | To measure hemoglobin difference and serum ferritin Receives: Diagnostic Test: Complete blood count |
| Ferrous sulphate | Experimental | To measure hemoglobin difference and serum ferritin Receives: Diagnostic Test: Complete blood count |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin level
Measure hemoglobin level two months after treatment
Measured: 2 months
Secondary outcomes (1)
Serum ferritin
Measure serum ferritin level
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start5 Sep 2017
- Primary completion10 Dec 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia of 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ragab, Ain Shams University
- Investigators
- Ahmed M Ragab, MBBCH, Principal investigator, Ainshams university maternity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456258
- Sponsor's protocol ID
- Ainshams maternity hospital
- Acronym
- Lactoferrin
- Status last verified
- Feb 2018
- First submitted
- 23 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy,a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03456258
- Acronym / sponsor ID
- Lactoferrin / Ainshams maternity hospital
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 7 Mar 2018 (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.
The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.
Detailed description
The study was done at ainshams university maternity hospital on 100 pregnant women randomized in two groups .
Group one lactoferrin group Group two ferrous sulphate group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin | Experimental | Diagnostic Test: Complete blood countTo measure hemoglobin difference and serum ferritin |
| Ferrous sulphate | Experimental | Diagnostic Test: Complete blood countTo measure hemoglobin difference and serum ferritin |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- pregnant women from 20 to 40 years
- iron deficiency anemia (mild and moderate)
- gestational age 13 to 26 weeks
- singleton viable pregnancy.
Key exclusion criteria (4 listed)
- history of anemia due to chronic blood loss
- hemolytic anemia
- severe anemia
- history of peptic ulcer
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 |
|---|---|---|
| Complete blood countAlso: Serum ferritinTo measure hemoglobin difference and serum ferritin levels . | Diagnostic test | Ferrous sulphate, Lactoferrin |
Primary outcome
hemoglobin level
Time frame: 2 months
Measure hemoglobin level two months after treatment
1 secondary outcome
Serum ferritin
Time frame: 2 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 7 Mar 2018.
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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 M Ragab, MBBCH principal investigator
Ainshams university maternity hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete blood count in people with Iron Deficiency Anemia of 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 4 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: finished, as of the sponsor's last update on 7 Mar 2018. 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?
hemoglobin level (time frame: 2 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 7 Mar 2018.