Evaluation of the Efficacy in Decreasing Iron Absorption in Patients With Congenital Dyserythropoietic Anemia Type I by Treatment With LOSEC
NCT ID: NCT01795794
Last Updated: 2013-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
12 participants
INTERVENTIONAL
2013-04-30
2013-12-31
Brief Summary
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The iron is being accumulated in the body \& causes damage of the liver, heart \& endocrine glands.
The standard follow up of iron levels is done by ferritin blood test \& although the test is not accurate it is the most available.
Medical treatment to removal of iron excess from the body is given in ferritin levels of 500-1000.
3 drugs are approved in the market:
* Deferoxamine, given subcutaneous during the night, 5-7 nights/week and therefore is less used today.
* Deferiprone-given 3 times a day, is a weaker chelator, although it seems like it is good to give it in combination with one of the 2 other drugs because it removes the iron from the heart's cells better.
A rare but severe adverse effect is Agranulocytosis. This drug is usually not given in childbirths.
-The 3rd drug which is mostly in use today is Deferasirox, given once daily, but has also adverse effects, among them- damage of liver \& kidney function, damage to the digestive system, hearing and seeing.
Iron is being absorbed in acidic area, \& thus drugs which decrease the acidity like hydrogen pump's inhibitors, can inhibit the absorption of iron, and indeed there are reports that these drugs decrease the absorption of iron and were used as treatment to hemochromatosis as well.
Those hydrogen pump's inhibitors have also adverse effects. The rarest but most severe is intestine infection by Clostridium.
In children, reports of adverse effects are minimal- mostly headaches \& abdominal pains and nosocomial infections. In adults, there are reports of fractures, magnesium deficiency \& vitamin B12 deficiency. All in all, the adverse effects are rare \& uncommon.
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Detailed Description
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Therefore, we would like to enroll 10-12 patients over 30 kg who can swallow tablets (age over 12) and whose ferritin levels are higher from the normal range, but still don't require medical treatment (ferritin levels between 400-700).
These patients will be given LOSEC 20 mg X 1/day for 6 months. That group will be her own control group in the 6 months later. Drug will be dispensed to the patients.
In the beginning of the study, after signing Informed Consent Form, blood tests will be taken for Complete Blood Count, iron levels, iron saturation, ferritin, complete chemistry panel, including calcium \& magnesium.
Same tests will be taken after 3 and 6 months and also 3 and 6 months after end of treatment.
In every event of fever, headaches, abdominal pain or diarrhea, patients need to apply the doctor and report.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LOSEC
LOSEC will be given 20 mg X 1/day for 6 months and then for the next 6 months the same group will be the "control" group of herself.
omeprazole
Interventions
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omeprazole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* over 30 kg
* can swallow tablets
* ferritin levels higher than the normal range but still don't require treatment.
Exclusion Criteria
12 Years
ALL
No
Sponsors
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Soroka University Medical Center
OTHER
Responsible Party
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Other Identifiers
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sor034612ctil
Identifier Type: -
Identifier Source: org_study_id
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