NCT04335058

Brief Summary

Iron deficiency and altered homeostasis due to inflammation and decreased iron utilization are main factors involved in anemia in liver disease. Lactoferrin is a first line defence protein for protection against microbial infections and subsequent development of systemic disease as seen with systemic inflammatory response syndrome (SIRS) and sepsis. Lactoferrin with iron has been shown to be efficacious with anemia in chronic disease, in pregnancy and in cancer patients with fewer side effects than oral iron alone. High exposure to iron is associated with increased inflammation which is associated with worse cardiovascular outcomes. Lactoferrin can help reduce the total iron dose and hepatic inflammation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

3.8 years

First QC Date

March 23, 2020

Last Update Submit

April 28, 2023

Conditions

Iron Deficiency AnemiaChronic Liver Failure

Outcome Measures

Primary Outcomes (2)

  • Correction of Anemia

    Number of participants achieving Hemoglobin level \> 12 g/dl iron deficiency anemia in patients with Chronic Liver Disease of any etiology.

    1 months

  • Correction of Anemia

    Number of participants achieving Hemoglobin level \> 12 g/dl

    3 months

Secondary Outcomes (1)

  • Reduction in Inflammatory markers

    3 months

Study Arms (2)

Group A: Lactoferrin plus oral iron

EXPERIMENTAL

Treated for 2 months regularly with oral administration of 100 mg Lactoferrin tablet twice a day before meals with oral administration of 100 mg of elemental iron capsules, one capsule twice daily on an empty stomach, at least 1 hour before or 2 hours after meals

Drug: Lactoferrin + Iron Supplement

Oral iron alone

ACTIVE COMPARATOR

Oral administration of 100 mg of elemental iron capsules, one capsule twice daily on an empty stomach, at least 1 hour before or 2 hours after meals

Drug: Iron Supplement

Interventions

Lactoferrin + Iron SupplementDRUG

Lactoferrin 100 mg twice daily +oral iron

Group A: Lactoferrin plus oral iron
Iron SupplementDRUG

Oral iron supplement alone

Oral iron alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years
  • Either gender
  • Patients with chronic liver disease with iron deficiency anemia with transferrin saturation\<20% and Hemoglobin in Non-pregnant women (15 years of age and above) \<12g/dl and in men \<13g/dl -

You may not qualify if:

  • Those who do not consent to participate in the study
  • Inability to obtain informed consent from patient or relatives
  • Severe preexisting cardiopulmonary disease
  • Renal dysfunction (S. Creatinine ≥ 2mg/dL)
  • Pregnancy/Lactation
  • Post liver transplant patients
  • HIV infection
  • Patients who are on psychoactive drugs, like sedatives or antidepressants
  • Patients who are too sick to carry out the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

Related Publications (6)

  • Iwasa M, Kaito M, Ikoma J, Takeo M, Imoto I, Adachi Y, Yamauchi K, Koizumi R, Teraguchi S. Lactoferrin inhibits hepatitis C virus viremia in chronic hepatitis C patients with high viral loads and HCV genotype 1b. Am J Gastroenterol. 2002 Mar;97(3):766-7. doi: 10.1111/j.1572-0241.2002.05573.x. No abstract available.

    PMID: 11922584BACKGROUND

  • Actor JK, Hwang SA, Kruzel ML. Lactoferrin as a natural immune modulator. Curr Pharm Des. 2009;15(17):1956-73. doi: 10.2174/138161209788453202.

    PMID: 19519436BACKGROUND

  • Elif M, Cooper JA. Upregulation Of Hepcidin Expression By Lactoferrin Administration To Pre-Weanling Mice. Blood, (2013) 122(21), 964.Accessed August 22, 2019.

    BACKGROUND

  • Manzoni P, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Stolfi I, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Saia OS, Maule M, Gallo E, Mostert M, Magnani C, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Mosca F, Ferrari F, Magaldi R, Stronati M, Farina D; Italian Task Force for the Study and Prevention of Neonatal Fungal Infections, Italian Society of Neonatology. Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low-birth-weight neonates: a randomized trial. JAMA. 2009 Oct 7;302(13):1421-8. doi: 10.1001/jama.2009.1403.

    PMID: 19809023BACKGROUND

  • Hayakawa T, Jin CX, Ko SB, Kitagawa M, Ishiguro H. Lactoferrin in gastrointestinal disease. Intern Med. 2009;48(15):1251-4. doi: 10.2169/internalmedicine.48.2199. Epub 2009 Aug 3.

    PMID: 19652425BACKGROUND

  • Lepanto MS, Rosa L, Cutone A, Conte MP, Paesano R, Valenti P. Efficacy of Lactoferrin Oral Administration in the Treatment of Anemia and Anemia of Inflammation in Pregnant and Non-pregnant Women: An Interventional Study. Front Immunol. 2018 Sep 21;9:2123. doi: 10.3389/fimmu.2018.02123. eCollection 2018.

    PMID: 30298070BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-DeficiencyEnd Stage Liver Disease

Interventions

LactoferrinIron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesGlycoproteinsGlycoconjugatesCarbohydratesTransferrinsIron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsLactoglobulinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsGlobulinsMetalloproteinsCoordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharides

Study Officials

  • Madhumita Premkumar, DM

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madhumita Premkumar, DM

CONTACT

01722756344drmadhumitap@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Department of Hepatology

Study Record Dates

First Submitted

March 23, 2020

First Posted

April 6, 2020

Study Start

January 1, 2020

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

May 1, 2023

Record last verified: 2023-04

Locations

IN(1)