Iron-deficiencyPhase 4NCT03542825
Oral Lactoferrin Versus Iron Supplementation During Pregnancy
A Phase 4 study testing Lactoferrin, Iron Supplement and Chelates, Iron in people with Iron-deficiency, run by South Valley University at 1 site in Egypt.
Trial summary
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores [Sharma JB; et al., 2004]. 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
- What is being tested?
- Lactoferrin, Iron Supplement and Chelates, Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Oct 2018
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women (aged 20-40 yrs.) with single fetus, in the second trimester, with normal haemoglobin level (Hb level ≥10.5 gm /dl) will be enrolled.
Who cannot join
- Women with anaemia (Hb level ≤10.5 gm. /dl) due to any causes, such as chronic blood loss, haemolytic anaemia and thalassemia (including thalassemia trait).
- History of peptic ulcer.
- Medical complications with pregnancy (such as cardiovascular, thyroid, pituitary, nutritional, renal, liver diseases, diabetes mellitus (DM) and hypertension (HTN).
- Fetal abnormalities such as microcephaly, intrauterine growth restriction (IUGR).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department
Qina, Qena Governorate
About this study
Official title: Outcome of Oral Lactoferrin in Comparison to Amino Acid Chelated Iron and Ferrous Sulphate Supplementation During Pregnancy: A Randomized Control Trial
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores [Sharma JB; et al., 2004]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection [ So¨lvell L; et al., 1970].
Read the detailed description
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores. This allows the normal mechanism of absorption to be used, in addition to being an inexpensive and effective treatment [Sharma JB; et al., 2004]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection [ So¨lvell L; et al., 1970].
Furthermore, routine iron supplementation has recently been challenged. The British Society for Hematology, Obstetric Hematology Group (BSH OHG) and the British Committee for Standards in Hematology (BCSH) recommend screening by Full blood count (FBC) at booking and at 28 weeks instead of universal iron supplementation [Pavord S. 2012]. Lactoferrin is a high-affinity cationic iron binding glycoprotein [Baker EN, 2005]. Bovine Lactoferrin is currently available pharmaceutical preparation. It is in to safe and effective in treating pregnant women suffering from ID and IDA [Mohamed Rezk, et al. 2015]. This study will compare the efficacy of these three available options.
- Conditions
- Iron-deficiency
- Being tested
- Lactoferrin, Iron Supplement, Chelates, Iron
- Keywords
- Iron, Deficiency
- 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.
LactoferrinDrug
parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia
Iron SupplementDrug
Also called Iron Sulphate
Iron Sulphate 150 mg once daily
Chelates, IronDrug
Also called Amino acid chelated iron
Amino acid chelated iron capsules contain 15 mg
| Study group | Role | What they receive |
|---|---|---|
| Iron Sulphate | Active comparator | ferrous sulphate 150 mg iron capsule once daily for 3 consecutive months. Receives: Drug: Iron Supplement |
| Amino acid Chelated | Active comparator | amino acid chelated iron capsule 15mg for 3 consecutive months. Receives: Drug: Chelates, Iron |
| Lactoferrin | Active comparator | lactoferrin 100 mg sachets once daily for 3 consecutive months. Receives: Drug: Lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in haemoglobin level after 4 weeks of use.
difference in haemoglobin levelbetween before and after supplementation
Measured: 4 weeks
Secondary outcomes (1)
side effect profile
All women will be asked to keep a diary of five potential gastrointestinal side effects (Epigastric pain, nausea, vomiting, diarrhoea and constipation).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Jan 2018
- Primary completion1 Sep 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups of pregnant women will be assigned for each intervention
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University
- Investigators
- Mohammad AM Ahmed, MD, Principal investigator, South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542825
- Sponsor's protocol ID
- OBGYN 003
- Status last verified
- Dec 2018
- First submitted
- 20 May 2018
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared in unanonomous manner with the predetermined group of researchers.
Publications
Sharma JB, Jain S, Mallika V, Singh T, Kumar A, Arora R, Murthy NS. A prospective, partially randomized study of pregnancy outcomes and hematologic responses to oral and intramuscular iron treatment in moderately anemic pregnant women. Am J Clin Nutr. 2004 Jan;79(1):116-22. doi: 10.1093/ajcn/79.1.116.
PubMed 14684407Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. doi: 10.1111/j.1365-2141.2011.09012.x.
PubMed 22512001Baker EN, Baker HM. Molecular structure, binding properties and dynamics of lactoferrin. Cell Mol Life Sci. 2005 Nov;62(22):2531-9. doi: 10.1007/s00018-005-5368-9.
PubMed 16261257Abu Hashim H, Foda O, Ghayaty E. Lactoferrin or ferrous salts for iron deficiency anemia in pregnancy: A meta-analysis of randomized trials. Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:45-52. doi: 10.1016/j.ejogrb.2017.10.003. Epub 2017 Oct 4.
PubMed 29059584
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Oral Lactoferrin in Comparison to Amino Acid Chelated Iron and Ferrous Sulphate Supplementation During Pregnancy: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03542825
- Acronym / sponsor ID
- OBGYN 003
- Conditions
- Iron-deficiency
- Keywords
- Iron, Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 31 May 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.
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores [Sharma JB; et al., 2004]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection [ So¨lvell L; et al., 1970].
Detailed description
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores. This allows the normal mechanism of absorption to be used, in addition to being an inexpensive and effective treatment [Sharma JB; et al., 2004]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection [ So¨lvell L; et al., 1970].
Furthermore, routine iron supplementation has recently been challenged. The British Society for Hematology, Obstetric Hematology Group (BSH OHG) and the British Committee for Standards in Hematology (BCSH) recommend screening by Full blood count (FBC) at booking and at 28 weeks instead of universal iron supplementation [Pavord S. 2012]. Lactoferrin is a high-affinity cationic iron binding glycoprotein [Baker EN, 2005]. Bovine Lactoferrin is currently available pharmaceutical preparation. It is in to safe and effective in treating pregnant women suffering from ID and IDA [Mohamed Rezk, et al. 2015]. This study will compare the efficacy of these three available options.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 3 groups of pregnant women will be assigned for each intervention
| Arm | Type | Receives |
|---|---|---|
| Iron Sulphate | Active comparator | Drug: Iron Supplementferrous sulphate 150 mg iron capsule once daily for 3 consecutive months. |
| Amino acid Chelated | Active comparator | Drug: Chelates, Ironamino acid chelated iron capsule 15mg for 3 consecutive months. |
| Lactoferrin | Active comparator | Drug: Lactoferrinlactoferrin 100 mg sachets once daily for 3 consecutive months. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women (aged 20-40 yrs.) with single fetus, in the second trimester, with normal haemoglobin level (Hb level ≥10.5 gm /dl) will be enrolled.
Key exclusion criteria (4 listed)
- Women with anaemia (Hb level ≤10.5 gm. /dl) due to any causes, such as chronic blood loss, haemolytic anaemia and thalassemia (including thalassemia trait).
- History of peptic ulcer.
- Medical complications with pregnancy (such as cardiovascular, thyroid, pituitary, nutritional, renal, liver diseases, diabetes mellitus (DM) and hypertension (HTN).
- Fetal abnormalities such as microcephaly, intrauterine growth restriction (IUGR).
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 |
|---|---|---|
| Lactoferrinparallel use of the three drugs to compare the efficacy of each arm in prevention of anemia | Drug | Lactoferrin |
| Iron SupplementAlso: Iron SulphateIron Sulphate 150 mg once daily | Drug | Iron Sulphate |
| Chelates, IronAlso: Amino acid chelated ironAmino acid chelated iron capsules contain 15 mg | Drug | Amino acid Chelated |
Primary outcome
change in haemoglobin level after 4 weeks of use.
Time frame: 4 weeks
difference in haemoglobin levelbetween before and after supplementation
1 secondary outcome
side effect profile
Time frame: 4 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 28 Dec 2018.
- Background: PubMed 14684407Sharma JB, Jain S, Mallika V, Singh T, Kumar A, Arora R, Murthy NS. A prospective, partially randomized study of pregnancy outcomes and hematologic responses to oral and intramuscular iron treatment in moderately anemic pregnant women. Am J Clin Nutr. 2004 Jan;79(1):116-22. doi: 10.1093/ajcn/79.1.116.
- Background: PubMed 22512001Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. doi: 10.1111/j.1365-2141.2011.09012.x.
- Background: PubMed 16261257Baker EN, Baker HM. Molecular structure, binding properties and dynamics of lactoferrin. Cell Mol Life Sci. 2005 Nov;62(22):2531-9. doi: 10.1007/s00018-005-5368-9.
- Background: PubMed 29059584Abu Hashim H, Foda O, Ghayaty E. Lactoferrin or ferrous salts for iron deficiency anemia in pregnancy: A meta-analysis of randomized trials. Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:45-52. doi: 10.1016/j.ejogrb.2017.10.003. Epub 2017 Oct 4.
- Individual participant dataSharing planned: Yes. IPD will be shared in unanonomous manner with the predetermined group of researchers.
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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.
Mohammad AM Ahmed, MD principal investigator
South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt
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 Lactoferrin, Iron Supplement and Chelates, Iron in people with Iron-deficiency, run by South Valley 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 1 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 28 Dec 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.
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?
change in haemoglobin level after 4 weeks of use. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03542825, which also lists 4 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 28 Dec 2018.