Iron Deficiency AnemiaNCT04335058
Lactoferrin in Treatment of Fe Deficient Anemia In Cirrhosis
A study testing Lactoferrin + Iron Supplement and Iron Supplement in people with Iron Deficiency Anemia and Chronic Liver Failure, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia, Chronic Liver Failure
- What is being tested?
- Lactoferrin + Iron Supplement and Iron Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Show all 9Show fewer
- HIV infection
- Patients who are on psychoactive drugs, like sedatives or antidepressants
- Patients who are too sick to carry out the protocol
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
Madhumita PREMKUMAR, DM, 01722756344, drmadhumitap@gmail.com
About this study
Official title: Lactoferrin With Iron Versus Iron Alone in Treatment of Anemia In Chronic Liver Disease
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.
Read the detailed description
Lactoferrin is a highly conserved, monomeric 80 kDa single polypeptide chain contained in most mammalian exocrine secretions, such as milk, saliva and tears, bronchial, and intestinal secretions. LTF is also found in the secondary granules of neutrophils a glycoprotein present in milk, has been demonstrated to possess a multitude of biological functions. Lactoferrin in Inflammation and Sepsis The antimicrobial activity of LTF is well documented and consists of two mechanisms: one is iron dependent and deals with high affinity of LTF to iron (bacteriostatic), and the other one is due to LTF affinity to lipopolysaccharide (LPS) to function as a direct bactericidal agent for Gram-negative organisms. Small changes, such as single nucleotide polymorphisms, can affect outcomes against pathogenic agents . LTF interacts with cell surface receptors involved in "danger signal" recognition [e.g., toll-like receptor (TLR)4, CD14, and CD22]. At the molecular level, LTF seems to reduce LPS-induced monocyte activation and subsequent production of pro-inflammatory mediators. Lactoferrin in Anemia in Liver Disease The hepatic expression of the hepcidin gene is regulated by signals which reflect body iron status and erythropoietic activity. The regulation of hepcidin by iron status includes a signal from the circulating transferrin via hepatocellular transferrin receptor (TfR2). Like transferrin, lactoferrin will deliver iron to hepatocytes but unlike transferrin, lactoferrin cannot deliver iron to erythroid cells. Lactoferrin does not interact with TfR1 or TfR2.
- Conditions
- Iron Deficiency Anemia, Chronic Liver Failure
- Being tested
- Lactoferrin + Iron Supplement, Iron Supplement
- Medical subject headings
- Anemia, Iron-Deficiency, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin + Iron SupplementDrug
Lactoferrin 100 mg twice daily +oral iron
Iron SupplementDrug
Oral iron supplement alone
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Iron Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of Anemia
Number of participants achieving Hemoglobin level > 12 g/dl iron deficiency anemia in patients with Chronic Liver Disease of any etiology.
Measured: 1 months
Correction of Anemia
Number of participants achieving Hemoglobin level > 12 g/dl
Measured: 3 months
Secondary outcomes (1)
Reduction in Inflammatory markers
IL-1, Hepcidin, Transferrin saturation measured
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Jan 2020
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Madhumita Premkumar, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335058
- Sponsor's protocol ID
- IEC/11/2019/1596
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2020
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11922584Actor JK, Hwang SA, Kruzel ML. Lactoferrin as a natural immune modulator. Curr Pharm Des. 2009;15(17):1956-73. doi: 10.2174/138161209788453202.
PubMed 19519436Elif M, Cooper JA. Upregulation Of Hepcidin Expression By Lactoferrin Administration To Pre-Weanling Mice. Blood, (2013) 122(21), 964.Accessed August 22, 2019.
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.
PubMed 19809023Hayakawa 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.
PubMed 19652425Lepanto 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.
PubMed 30298070
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin With Iron Versus Iron Alone in Treatment of Anemia In Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT04335058
- Acronym / sponsor ID
- IEC/11/2019/1596
- Conditions
- Iron Deficiency Anemia, Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lactoferrin is a highly conserved, monomeric 80 kDa single polypeptide chain contained in most mammalian exocrine secretions, such as milk, saliva and tears, bronchial, and intestinal secretions. LTF is also found in the secondary granules of neutrophils a glycoprotein present in milk, has been demonstrated to possess a multitude of biological functions. Lactoferrin in Inflammation and Sepsis The antimicrobial activity of LTF is well documented and consists of two mechanisms: one is iron dependent and deals with high affinity of LTF to iron (bacteriostatic), and the other one is due to LTF affinity to lipopolysaccharide (LPS) to function as a direct bactericidal agent for Gram-negative organisms. Small changes, such as single nucleotide polymorphisms, can affect outcomes against pathogenic agents . LTF interacts with cell surface receptors involved in "danger signal" recognition [e.g., toll-like receptor (TLR)4, CD14, and CD22]. At the molecular level, LTF seems to reduce LPS-induced monocyte activation and subsequent production of pro-inflammatory mediators. Lactoferrin in Anemia in Liver Disease The hepatic expression of the hepcidin gene is regulated by signals which reflect body iron status and erythropoietic activity. The regulation of hepcidin by iron status includes a signal from the circulating transferrin via hepatocellular transferrin receptor (TfR2). Like transferrin, lactoferrin will deliver iron to hepatocytes but unlike transferrin, lactoferrin cannot deliver iron to erythroid cells. Lactoferrin does not interact with TfR1 or TfR2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Group A: Lactoferrin plus oral iron | Experimental | Drug: Lactoferrin + Iron SupplementTreated 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 |
| Oral iron alone | Active comparator | Drug: Iron SupplementOral 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoferrin + Iron SupplementLactoferrin 100 mg twice daily +oral iron | Drug | Group A: Lactoferrin plus oral iron |
| Iron SupplementOral iron supplement alone | Drug | Oral iron alone |
Primary outcome
Correction of Anemia
Time frame: 1 months
Number of participants achieving Hemoglobin level > 12 g/dl iron deficiency anemia in patients with Chronic Liver Disease of any etiology.
Correction of Anemia
Time frame: 3 months
Number of participants achieving Hemoglobin level > 12 g/dl
1 secondary outcome
Reduction in Inflammatory markers
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Background: PubMed 11922584Iwasa 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.
- Background: PubMed 19519436Actor JK, Hwang SA, Kruzel ML. Lactoferrin as a natural immune modulator. Curr Pharm Des. 2009;15(17):1956-73. doi: 10.2174/138161209788453202.
- BackgroundElif M, Cooper JA. Upregulation Of Hepcidin Expression By Lactoferrin Administration To Pre-Weanling Mice. Blood, (2013) 122(21), 964.Accessed August 22, 2019.
- Background: PubMed 19809023Manzoni 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.
- Background: PubMed 19652425Hayakawa 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.
- Background: PubMed 30298070Lepanto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhumita Premkumar, DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin + Iron Supplement and Iron Supplement in people with Iron Deficiency Anemia and Chronic Liver Failure, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madhumita Premkumar, DM (01722756344, drmadhumitap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of Anemia (time frame: 1 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335058, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.