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CompletedNCT03481790Updated Mar 29, 2018

Lactoferrin Versus Ferrous Sulphate for Treatment of Iron Deficiency Anaemia During Pregnancy

A Phase 2 interventional study of Lactoferrin and ferrous sulphate + folic acid (vitamin B9) in Iron Deficiency Anemia of Pregnancy, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Ain Shams Maternity Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy.

Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.

Read the detailed description

Lactoferrin and Ferrous sulfate are used to treat iron deficiency anemia in pregnancy.

Ferrous sulphate is the most commonly used treatment for iron deficiency anemia.

Lactoferrin is a new generation oral iron that has long been recognized as a member of the transferrin family of proteins and an important regulator of the levels of free iron in the body fluids and has the ability to enhance iron binding. Preliminary evidence suggests that lactoferrin may represent a promising new strategy for oral iron replacement.

02

Conditions studied

  • Iron Deficiency Anemia of Pregnancy

Keywords

  • iron deficiency anemia of pregnancy - lactoferrin
03

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Pregnant women with single fetus
  • Hb count \< 11g/dL
  • ferritin level \< 12 ng/dL
  • Gestational age (14 - 30 weeks)

Exclusion criteria

Exclusion Criteria:

  • Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
  • Associated bleeding disorder
  • Anaemia requiring blood tranfusion (Hb \< 7g/dL)
  • Hypersensitivity to iron preparations
  • Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Lactoferrin

    100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day.

    Drug: Lactoferrin

  • Experimental
    ferrous sulphate + folic acid (vitamin B9)

    150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day.

    Drug: ferrous sulphate + folic acid (vitamin B9)

Interventions

  • DrugLactoferrin

    (Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.

    Also known as: Pravotin, MamyVital

  • Drugferrous sulphate + folic acid (vitamin B9)

    (Ferrofol capsules, Eipico, Egypt): Dried ferrous sulphate 150 mg + Folic acid (Vitamin B9) 150 mg at least 1 hour before or 2 hours after meals three times a day for 4 weeks.

    Also known as: Ferrofol

05

What researchers measure

Primary outcomes

  1. Hemoglobin (Hb) level.

    to be measured before and after treatment.

    Time frame: 4 weeks

Secondary outcomes

  1. serum ferritin level.

    to be measured before and after treatment.

    Time frame: 4 weeks

06

Study locations

1 site
  • Ain Shams Maternity Hospital
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03481790
Lead sponsor
Ain Shams Maternity Hospital
Responsible party
Khaled Mohamed Balsha (principal investigator, Ain Shams Maternity Hospital) — Principal investigator
First posted
Mar 29, 2018
Start date
Sep 1, 2017
Primary completion
Mar 5, 2018
Completion
Mar 5, 2018
Last update
Mar 29, 2018

Study contacts

Ahmed Mamdouh
study director · Ain Shams Maternity Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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