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NCT Number: NCT03759353

Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance.

Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. It represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects.

This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ain SHams Maternity Hospital

Cairo, Abbaseya, 002, Egypt

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.
  • Second trimester (14-20weeks of gestation).
  • Normal Hemoglobin level: more than10g\\dl.
  • Serum ferritin less than 15 mcg / L

Exclusion criteria

  • Other type than iron-deficiency anemia (thalassemia, hemolytic anemia … etc.)
  • Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases … etc.)
  • Having hypersensitivity to iron preparations.
  • Treatment with any other iron preparation in the last month.
  • History of peptic ulcer, oesophagitis or hiatal hernia.
  • Medical disorders with pregnancy.
  • Need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) .
  • Bleeding in early pregnancy.
  • Refusal to participate in the study.
  • Family history of thalassemia-sickle cell anemia or malabsorption syndrome.
  • Recent blood transfusion.
  • Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.

Treatment and study plan

Baseline ferritin level

Diagnostic Test

At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.

Lactoferrin

Drug

lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).

Other names: Pravotin

Ferrous Sulfate

Drug

200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.

Other names: Feosol

Follow up ferritin level

Diagnostic Test

Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.

Primary outcomes

  1. Change in serum ferritin level

    Time frame: 4 weeks

    Change in serum ferritin level between enrollment and 4 weeks post-treatment.

Secondary outcomes

  1. Nausea and/or vomiting

    Time frame: 4 weeks

    Incidence of treatment-related nausea and/or vomiting

  2. Dyspepsia

    Time frame: 4 weeks

    Incidence of treatment-related dyspepsia

  3. Compliance to treatment

    Time frame: 4 weeks

    Number of missed doses of treatment from the assigned 30 doses

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2018
Registry last updated
Nov 30, 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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