Oral Lactoferrin Versus Iron Supplementation During Pregnancy

December 27, 2018 updated by: Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University

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].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iron Sulphate
ferrous sulphate 150 mg iron capsule once daily for 3 consecutive months.
Drug: Iron Supplement
Iron Sulphate 150 mg once daily
Other Names:
  • Iron Sulphate
Active Comparator: Amino acid Chelated
amino acid chelated iron capsule 15mg for 3 consecutive months.
Drug: Chelates, Iron
Amino acid chelated iron capsules contain 15 mg
Other Names:
  • Amino acid chelated iron
Active Comparator: Lactoferrin
lactoferrin 100 mg sachets once daily for 3 consecutive months.
Drug: Lactoferrin
parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in haemoglobin level after 4 weeks of use.
Time Frame: 4 weeks
difference in haemoglobin levelbetween before and after supplementation
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effect profile
Time Frame: 4 weeks
All women will be asked to keep a diary of five potential gastrointestinal side effects (Epigastric pain, nausea, vomiting, diarrhoea and constipation).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

May 20, 2018

First Submitted That Met QC Criteria

May 20, 2018

First Posted (Actual)

May 31, 2018

Study Record Updates

Last Update Posted (Actual)

December 28, 2018

Last Update Submitted That Met QC Criteria

December 27, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBGYN 003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD will be shared in unanonomous manner with the predetermined group of researchers.

IPD Sharing Time Frame

throughout the period of research until end of the study

IPD Sharing Access Criteria

IPD will be shared with the predetermined group of researchers as accepted by the local ethical and research committee.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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