Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

NCT03759353 | Completed Phase 2 DMC

• 1 other identifier: LactvsFerr
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Change in serum ferritin level

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

  4 weeks

Secondary Outcomes (3)

• Nausea and/or vomiting

  4 weeks

• Dyspepsia

  4 weeks

• Compliance to treatment

  4 weeks

Study Arms (2)

Lactoferrin Group

ACTIVE COMPARATOR

Includes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.

Diagnostic Test: Baseline ferritin level; Drug: Lactoferrin; Diagnostic Test: Follow up ferritin level

Ferrous Sulfate Group

ACTIVE COMPARATOR

Includes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.

Diagnostic Test: Baseline ferritin level; Drug: Ferrous Sulfate; Diagnostic Test: Follow up ferritin level

Interventions

Baseline ferritin level DIAGNOSTIC_TEST

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

Ferrous Sulfate Group; Lactoferrin Group

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).

Also known as: Pravotin

Lactoferrin Group

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.

Also known as: Feosol

Ferrous Sulfate Group

Follow up ferritin level DIAGNOSTIC_TEST

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

Ferrous Sulfate Group; Lactoferrin Group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain SHams Maternity Hospital

Cairo, Abbaseya, 002, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Lactoferrin; ferrous sulfate; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins; Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides

Study Officials

• Ghada Mohamed, MBBCh

  G Darwish

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of O&G

Model Details: 98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 30, 2018
• Study Start: January 15, 2018
• Primary Completion: October 30, 2018
• Study Completion: November 20, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)