Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy

NCT03484845 | Unknown Phase 1

• 1 other identifier: u1111-1210-1436
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy.

Conditions

Iron Deficiency Anemia of Pregnancy

Outcome Measures

Primary Outcomes (1)

• Increase in blood hemoglobin.

  mean difference in hemoglobin level between pre treatment and post treatment.

  one month

Study Arms (3)

Oral lactoferrin

ACTIVE COMPARATOR

women who take oral lactoferrin sachets 100 mg twice daily for one month.

Drug: Lactoferrin and ferrous fumarate

Oral ferrous fumarate

ACTIVE COMPARATOR

women who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month.

Drug: Lactoferrin and ferrous fumarate

Combined lactoferrin & ferrous fumarate

ACTIVE COMPARATOR

women who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month.

Drug: Lactoferrin and ferrous fumarate

Interventions

Lactoferrin and ferrous fumarate DRUG

* Group 1:include 50 women will receive oral lactoferrin 100mg twice daily . * Group 2: include 50 women will receive oral Ferrous fumarate 30mg elemental iron twice daily . * Group 3: include 50 women will receive oral combined lactoferrin 200mg and ferrous fumarate 60mg elemental iron once daily .

Also known as: pravotin sachets and vitayami tablets

Combined lactoferrin & ferrous fumarate; Oral ferrous fumarate; Oral lactoferrin

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women from 24-36 weeks of gestation.
• Mild to moderate anemia.

You may not qualify if:

• Women with a history of anemia due to any other causes other than IDA.
• Severe anemia requiring blood transfusion.
• History of peptic ulcer.
• known hypersensitivity to iron preparations.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Lactoferrin; ferrous fumarate

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

Central Study Contacts

amaal khalil, master

CONTACT

02201154883113; amaal.moussa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 2, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 3, 2018

Record last verified: 2018-06