Lactoferrin for Treatment of Iron Deficiency Anemia.

NCT04435574 | Completed Phase 4

• 1 other identifier: 70777
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Anemia is a great public health problem affecting both developing and developed countries. Iron deficiency anemia represents about 50% of causes of anemia worldwide. Lactoferrin fortified milk has a positive effect on Hb and iron status of infants. the hypothesis of this study is "lactoferrin may have comparable efficacy to ferrous sulfate therapy with more tolerability and fewer side effects". the research question of this study is whether oral lactoferrin is effective for treatment of iron deficiency anemia, compared to traditional ferrous sulfate therapy regarding hemoglobin rise and side effects and tolerability.

Conditions

Anemia, Iron Deficiency

Outcome Measures

Primary Outcomes (2)

• Hemoglobin

  hemoglobin%

  8 weeks

• Total serum iron

  Total serum iron

  8 weeks

Secondary Outcomes (1)

• Side effects profile

  4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

group A is lactoferrin group, receiving 100mg sachet of lactoferrin once daily.

Drug: Lactoferrin

Group b

ACTIVE COMPARATOR

group B is the ferrous sulfate group, receiving 6mg/kg/ day single dose of ferrous sulfate.

Drug: Ferrous Sulfate

Interventions

Lactoferrin DRUG

Bovine Lactoferrin 100mg sachets.

Group A

Ferrous Sulfate DRUG

6mg/kg of ferrous sulfate.

Group b

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with iron deficiency anemia.

You may not qualify if:

• Malabsorption diseases as coeliac disease.
• Diseases causing chronic blood loss as Meckel diverticulum.
• Documented history of allergy to lactoferrin or ferrous sulfate.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Primary care center

Giza, 12561, Egypt

Location

Related Publications (4)

• Stoltzfus R. Defining iron-deficiency anemia in public health terms: a time for reflection. J Nutr. 2001 Feb;131(2S-2):565S-567S. doi: 10.1093/jn/131.2.565S.

  PMID: 11160589 BACKGROUND

• Paesano R, Torcia F, Berlutti F, Pacifici E, Ebano V, Moscarini M, Valenti P. Oral administration of lactoferrin increases hemoglobin and total serum iron in pregnant women. Biochem Cell Biol. 2006 Jun;84(3):377-80. doi: 10.1139/o06-040.

  PMID: 16936810 BACKGROUND

• Paesano R, Pietropaoli M, Gessani S, Valenti P. The influence of lactoferrin, orally administered, on systemic iron homeostasis in pregnant women suffering of iron deficiency and iron deficiency anaemia. Biochimie. 2009 Jan;91(1):44-51. doi: 10.1016/j.biochi.2008.06.004. Epub 2008 Jun 14.

  PMID: 18601971 BACKGROUND

• Rezk M, Dawood R, Abo-Elnasr M, Al Halaby A, Marawan H. Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial. J Matern Fetal Neonatal Med. 2016;29(9):1387-90. doi: 10.3109/14767058.2015.1049149. Epub 2015 Jun 3.

  PMID: 26037728 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Lactoferrin; ferrous sulfate

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

Study Officials

• Ghada Khfaji, Associate professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of family medicine

Model Details: the population for the study will be Scholar age Children attend family medicine clinic for treatment of iron deficiency anemia and their parents accept participation in the study. For confirmation of the diagnosis of iron deficiency anemia the following investigations will be done: * CBC * Serum total iron full medical history and examination will be performed. study participants will be assigned to either group A (lactoferrin group) or group B (ferrous sulfate group), and will receive the corresponding medication for 8 weeks. 4 weeks follow up for side effects and hemoglobin level and 8 weeks follow up for side effects, hemoglobin level and serum iron will be performed.

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: June 17, 2020
• Study Start: September 5, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: June 17, 2020

Record last verified: 2020-06

Locations

EG (1)