Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis
NCT ID: NCT01524757
Last Updated: 2012-02-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-03-31
Study Completion Date
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hereditary Hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload causing damage of different important organs like heart, liver, pancreas and joints. Complications and symptoms can regress by intensive treatment reducing the iron overload stores.Different genes have been identified playing a role in the pathophysiology of iron overload. A clinically important HFE gene mutation is the C282Y, located on chromosome 6. Phlebotomy is currently the standard therapy which consists of removal of 500 ml whole blood weekly, representing a loss of 250 mg iron. In naive patients between 20 to 100 phlebotomies are required to reduce the serum ferritine levels to 50 μg/L. Thereafter, a lifelong maintenance therapy of 3 to 6 phlebotomies yearly is needed.
For absorption, dietary iron ( 70%) is reduced by gastric acid form the ferric (Fe3+) to the ferrous form (Fe2+). Recently, in an observational open study, Hutchinson et al. found that HH patients treated with proton pump inhibitors (PPI) needed fewer phlebotomies, resulting in a drop of 2.5 (SEM 0.25) to 0.5 (SEM 0.25) liter per year.
Research question: The primary objective is to determine the effectiveness and cost effectiveness of PPI's compared to standard phlebotomy therapy in the prevention of iron overload in HH patients.
Multi-center trial in two hospitals in the South of Limburg (Atrium medical Center, Maastricht university medical center ) and hospital in Belgium (University Hospital Gasthuisberg). The study will be conducted in randomised double blind manner. The follow up will be one year.
Patients are randomized either for the group receiving a PPI or a placebo. Every 2 month the ferritin level is measured and decided if the patient need a phlebotomy (Ferritin \>100 µg/L).
For absorption, dietary iron ( 70%) is reduced by gastric acid form the ferric (Fe3+) to the ferrous form (Fe2+). Recently, in an observational open study, Hutchinson et al. found that HH patients treated with proton pump inhibitors (PPI) needed fewer phlebotomies, resulting in a drop of 2.5 (SEM 0.25) to 0.5 (SEM 0.25) liter per year.
Research question: The primary objective is to determine the effectiveness and cost effectiveness of PPI's compared to standard phlebotomy therapy in the prevention of iron overload in HH patients.
Multi-center trial in two hospitals in the South of Limburg (Atrium medical Center, Maastricht university medical center ) and hospital in Belgium (University Hospital Gasthuisberg). The study will be conducted in randomised double blind manner. The follow up will be one year.
Patients are randomized either for the group receiving a PPI or a placebo. Every 2 month the ferritin level is measured and decided if the patient need a phlebotomy (Ferritin \>100 µg/L).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Clinical Significance of Acid Rebound in Functional Dyspepsia
NCT01373970
Functional Dyspepsia
TERMINATED
PHASE4
Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)
NCT00325676
Gastroesophageal Reflux Disease
COMPLETED
PHASE4
Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers
NCT00915239
Healthy
COMPLETED
NA
A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD) and a History of Nighttime Heartburn
NCT00237367
Gastroesophageal Reflux
COMPLETED
PHASE4
Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)
NCT00247715
Dyspepsia
Gastrointestinal Diseases
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Hemochromatosis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pantoprazol
Group Type
EXPERIMENTAL
Pantoprazole
Intervention Type
DRUG
pantoprazole 40mg 1dd1; 12 months
placebo
Group Type
PLACEBO_COMPARATOR
Pantoprazole
Intervention Type
DRUG
pantoprazole 40mg 1dd1; 12 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pantoprazole
pantoprazole 40mg 1dd1; 12 months
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with hereditary hemochromatosis (HH), homozygous for C282Y, currently treated with phlebotomy as maintenance therapy for at least 12 months with ≥ 3 phlebotomies per year.
* Ferritin level between 50-100 μg/L at start of the inclusion.
* Age: 18 years- 60 years and weight \> 50 kg.
* Ferritin level between 50-100 μg/L at start of the inclusion.
* Age: 18 years- 60 years and weight \> 50 kg.
Exclusion Criteria
* Patients receiving other therapies such as chelating therapy or forced dietary regimen.
* Patients younger than 18 years.
* HH patients with excessive overweight (BMI \> 35).
* Patients who are mentally incapacitated.
* Women being pregnant or expecting/ planning to become pregnant during the one year period of the study.
* Patients with a malignancy.
* Patients already on PPI treatment.
* Patients who experienced side effects of PPI's.
* Patients younger than 18 years.
* HH patients with excessive overweight (BMI \> 35).
* Patients who are mentally incapacitated.
* Women being pregnant or expecting/ planning to become pregnant during the one year period of the study.
* Patients with a malignancy.
* Patients already on PPI treatment.
* Patients who experienced side effects of PPI's.
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Annadal stichting
UNKNOWN
Sponsor Role
collaborator
Maastricht University Medical Center
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
G Koek, Dr
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University hospital Gasthuisberg
Leuven, Limburg, Belgium
Site Status
Atrium MC Parkstad
Heerlen, Limburg, Netherlands
Site Status
Maastricht university medical center
Maastricht, Limburg, Netherlands
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Belgium
Netherlands
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Hutchinson C, Geissler CA, Powell JJ, Bomford A. Proton pump inhibitors suppress absorption of dietary non-haem iron in hereditary haemochromatosis. Gut. 2007 Sep;56(9):1291-5. doi: 10.1136/gut.2006.108613. Epub 2007 Mar 7.
Reference Type
BACKGROUND
Adams P, Brissot P, Powell LW. EASL International Consensus Conference on Haemochromatosis. J Hepatol. 2000 Sep;33(3):485-504. doi: 10.1016/s0168-8278(01)80874-6. No abstract available.
Reference Type
BACKGROUND
Pietrangelo A. Hereditary hemochromatosis. Biochim Biophys Acta. 2006 Jul;1763(7):700-10. doi: 10.1016/j.bbamcr.2006.05.013. Epub 2006 May 27.
Reference Type
BACKGROUND
van der Plas SM, Hansen BE, de Boer JB, Stijnen T, Passchier J, de Man RA, Schalm SW. Generic and disease-specific health related quality of life of liver patients with various aetiologies: a survey. Qual Life Res. 2007 Apr;16(3):375-88. doi: 10.1007/s11136-006-9131-y. Epub 2006 Nov 25.
Reference Type
BACKGROUND
European Association For The Study Of The Liver. EASL clinical practice guidelines for HFE hemochromatosis. J Hepatol. 2010 Jul;53(1):3-22. doi: 10.1016/j.jhep.2010.03.001. Epub 2010 Apr 18.
Reference Type
BACKGROUND
Jacobs EM, Meulendijks CF, Elving L, van der Wilt GJ, Swinkels DW. Impact of the introduction of a guideline on the targeted detection of hereditary haemochromatosis. Neth J Med. 2005 Jun;63(6):205-14.
Reference Type
BACKGROUND
Swinkels DW, Janssen MC, Bergmans J, Marx JJ. Hereditary hemochromatosis: genetic complexity and new diagnostic approaches. Clin Chem. 2006 Jun;52(6):950-68. doi: 10.1373/clinchem.2006.068684. Epub 2006 Apr 20.
Reference Type
BACKGROUND
Rombout-Sestrienkova E, Nieman FH, Essers BA, van Noord PA, Janssen MC, van Deursen CT, Bos LP, Rombout F, van den Braak R, de Leeuw PW, Koek GH. Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial. Transfusion. 2012 Mar;52(3):470-7. doi: 10.1111/j.1537-2995.2011.03292.x. Epub 2011 Aug 16.
Reference Type
BACKGROUND
Hungin AP, Rubin G, O'Flanagan H. Factors influencing compliance in long-term proton pump inhibitor therapy in general practice. Br J Gen Pract. 1999 Jun;49(443):463-4.
Reference Type
BACKGROUND
Hicken BL, Tucker DC, Barton JC. Patient compliance with phlebotomy therapy for iron overload associated with hemochromatosis. Am J Gastroenterol. 2003 Sep;98(9):2072-7. doi: 10.1111/j.1572-0241.2003.07292.x.
Reference Type
BACKGROUND
Bonapace ES, Fisher RS, Parkman HP. Does fasting serum gastrin predict gastric acid suppression in patients on proton-pump inhibitors? Dig Dis Sci. 2000 Jan;45(1):34-9. doi: 10.1023/a:1005496907686.
Reference Type
BACKGROUND
Newman BH. Blood donor complications after whole-blood donation. Curr Opin Hematol. 2004 Sep;11(5):339-45. doi: 10.1097/01.moh.0000142105.21058.96.
Reference Type
BACKGROUND
HOFSTETTER JR. [Risks in blood-letting in therapy of hemochromatosis]. Gastroenterologia. 1957;87(3-4):186-91. No abstract available. French.
Reference Type
BACKGROUND
Klinkenberg-Knol EC, Festen HP, Jansen JB, Lamers CB, Nelis F, Snel P, Luckers A, Dekkers CP, Havu N, Meuwissen SG. Long-term treatment with omeprazole for refractory reflux esophagitis: efficacy and safety. Ann Intern Med. 1994 Aug 1;121(3):161-7. doi: 10.7326/0003-4819-121-3-199408010-00001.
Reference Type
BACKGROUND
Klinkenberg-Knol EC, Nelis F, Dent J, Snel P, Mitchell B, Prichard P, Lloyd D, Havu N, Frame MH, Roman J, Walan A; Long-Term Study Group. Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa. Gastroenterology. 2000 Apr;118(4):661-9. doi: 10.1016/s0016-5085(00)70135-1.
Reference Type
BACKGROUND
Creutzfeldt W, Lamberts R. Is hypergastrinaemia dangerous to man? Scand J Gastroenterol Suppl. 1991;180:179-91. doi: 10.3109/00365529109093198.
Reference Type
BACKGROUND
Solcia E, Fiocca R, Havu N, Dalvag A, Carlsson R. Gastric endocrine cells and gastritis in patients receiving long-term omeprazole treatment. Digestion. 1992;51 Suppl 1:82-92. doi: 10.1159/000200921.
Reference Type
BACKGROUND
Lamberts R, Brunner G, Solcia E. Effects of very long (up to 10 years) proton pump blockade on human gastric mucosa. Digestion. 2001;64(4):205-13. doi: 10.1159/000048863.
Reference Type
BACKGROUND
Hallerback B, Unge P, Carling L, Edwin B, Glise H, Havu N, Lyrenas E, Lundberg K. Omeprazole or ranitidine in long-term treatment of reflux esophagitis. The Scandinavian Clinics for United Research Group. Gastroenterology. 1994 Nov;107(5):1305-11. doi: 10.1016/0016-5085(94)90531-2.
Reference Type
BACKGROUND
Lamberts R, Creutzfeldt W, Struber HG, Brunner G, Solcia E. Long-term omeprazole therapy in peptic ulcer disease: gastrin, endocrine cell growth, and gastritis. Gastroenterology. 1993 May;104(5):1356-70. doi: 10.1016/0016-5085(93)90344-c.
Reference Type
BACKGROUND
Sharma BK, Santana IA, Wood EC, Walt RP, Pereira M, Noone P, Smith PL, Walters CL, Pounder RE. Intragastric bacterial activity and nitrosation before, during, and after treatment with omeprazole. Br Med J (Clin Res Ed). 1984 Sep 22;289(6447):717-9. doi: 10.1136/bmj.289.6447.717.
Reference Type
BACKGROUND
Fried M, Siegrist H, Frei R, Froehlich F, Duroux P, Thorens J, Blum A, Bille J, Gonvers JJ, Gyr K. Duodenal bacterial overgrowth during treatment in outpatients with omeprazole. Gut. 1994 Jan;35(1):23-6. doi: 10.1136/gut.35.1.23.
Reference Type
BACKGROUND
Verdu E, Viani F, Armstrong D, Fraser R, Siegrist HH, Pignatelli B, Idstrom JP, Cederberg C, Blum AL, Fried M. Effect of omeprazole on intragastric bacterial counts, nitrates, nitrites, and N-nitroso compounds. Gut. 1994 Apr;35(4):455-60. doi: 10.1136/gut.35.4.455.
Reference Type
BACKGROUND
Laheij RJ, Sturkenboom MC, Hassing RJ, Dieleman J, Stricker BH, Jansen JB. Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA. 2004 Oct 27;292(16):1955-60. doi: 10.1001/jama.292.16.1955.
Reference Type
BACKGROUND
Koop H, Bachem MG. Serum iron, ferritin, and vitamin B12 during prolonged omeprazole therapy. J Clin Gastroenterol. 1992 Jun;14(4):288-92. doi: 10.1097/00004836-199206000-00005.
Reference Type
BACKGROUND
Termanini B, Gibril F, Sutliff VE, Yu F, Venzon DJ, Jensen RT. Effect of long-term gastric acid suppressive therapy on serum vitamin B12 levels in patients with Zollinger-Ellison syndrome. Am J Med. 1998 May;104(5):422-30. doi: 10.1016/s0002-9343(98)00087-4.
Reference Type
BACKGROUND
Vanclooster A, van Deursen C, Jaspers R, Cassiman D, Koek G. Proton Pump Inhibitors Decrease Phlebotomy Need in HFE Hemochromatosis: Double-Blind Randomized Placebo-Controlled Trial. Gastroenterology. 2017 Sep;153(3):678-680.e2. doi: 10.1053/j.gastro.2017.06.006. Epub 2017 Jun 15.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL3364409612
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
NCT00037570
COMPLETED
PHASE2
Placebo-Controlled Crossover Study for the Investigation of the Effect of Pantoprazole on Cardiac Contractility
NCT00600041
COMPLETED
PHASE1
Effect of Daily Use Proton Pump Inhibitors for One Month on Kidney Function
NCT03910647
UNKNOWN
PHASE2
On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication
NCT00161096
UNKNOWN
PHASE3
Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease
NCT00829738
COMPLETED
PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena
NCT00526006
UNKNOWN
PHASE4
Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed
NCT02235311
TERMINATED
NA
iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
NCT02552537
COMPLETED
PHASE4
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
NCT00261300
COMPLETED
PHASE3
Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients?
NCT02841852
COMPLETED
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
NCT00251732
COMPLETED
PHASE4
Study Evaluating Pantoprazole in Children With GERD
NCT00141817
COMPLETED
PHASE3
ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
NCT00810485
COMPLETED
PHASE2
A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755
NCT07141381
RECRUITING
PHASE1
Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban Over 5 Days in Healthy Subjects
NCT02264106
COMPLETED
PHASE1
Study Evaluating Pantoprazole in Adolescents With GERD
NCT00367614
COMPLETED
PHASE3
Prevalence and Intervention of Hypomagnesemia in Users of Proton-pump Inhibitors
NCT02518659
COMPLETED
NA
High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding
NCT00374101
COMPLETED
PHASE3
Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
NCT00363701
UNKNOWN
PHASE4
Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis
NCT01182597
UNKNOWN
PHASE3
Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)
NCT01128127
WITHDRAWN
NA
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
NCT00259012
COMPLETED
PHASE3
Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population
NCT03118778
COMPLETED