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Oral Lactoferrin Versus Iron Supplementation During Pregnancy

NCT ID: NCT03542825

Last Updated: 2018-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-10-01

Brief Summary

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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

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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

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Iron-deficiency

Keywords

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 groups of pregnant women will be assigned for each intervention
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
Double blinded (participant and care giver)

Study Groups

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Iron Sulphate

ferrous sulphate 150 mg iron capsule once daily for 3 consecutive months.

Group Type ACTIVE_COMPARATOR

Iron Supplement

Intervention Type DRUG

Iron Sulphate 150 mg once daily

Amino acid Chelated

amino acid chelated iron capsule 15mg for 3 consecutive months.

Group Type ACTIVE_COMPARATOR

Chelates, Iron

Intervention Type DRUG

Amino acid chelated iron capsules contain 15 mg

Lactoferrin

lactoferrin 100 mg sachets once daily for 3 consecutive months.

Group Type ACTIVE_COMPARATOR

Lactoferrin

Intervention Type DRUG

parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia

Interventions

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Lactoferrin

parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia

Intervention Type DRUG

Iron Supplement

Iron Sulphate 150 mg once daily

Intervention Type DRUG

Chelates, Iron

Amino acid chelated iron capsules contain 15 mg

Intervention Type DRUG

Other Intervention Names

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Iron Sulphate Amino acid chelated iron

Eligibility Criteria

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Inclusion Criteria

• 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Abdel-Rahman Mohammad Ahmed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad AM Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt

Locations

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South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department

Qina, Qena Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 14684407 (View on PubMed)

Pavord 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.

Reference Type BACKGROUND
PMID: 22512001 (View on PubMed)

Baker 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.

Reference Type BACKGROUND
PMID: 16261257 (View on PubMed)

Abu 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.

Reference Type BACKGROUND
PMID: 29059584 (View on PubMed)

Other Identifiers

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OBGYN 003

Identifier Type: -

Identifier Source: org_study_id