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Completed

NCT Number: NCT03481790

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

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.

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Key information

Conditions

Iron Deficiency Anemia of Pregnancy

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams Maternity Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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)

Treatment and study plan

Lactoferrin

Drug

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

Other names: Pravotin, MamyVital

ferrous sulphate + folic acid (vitamin B9)

Drug

(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.

Other names: Ferrofol

Primary outcomes

  1. Hemoglobin (Hb) level.

    Time frame: 4 weeks

    to be measured before and after treatment.

Secondary outcomes

  1. serum ferritin level.

    Time frame: 4 weeks

    to be measured before and after treatment.

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

The Effect of Orally Administered Iron-saturated Lactoferrin on Systemic Iron Homeostasis in Pregnant Women Suffering From Iron Deficiency and Iron Deficiency Anaemia

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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