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| Name | Class |
|---|---|
| Mahidol University | OTHER |
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Genetic disorders, such as thalassemia, can lead to iron overload and severe adverse health outcomes. In iron-loading thalassemia, iron overload is due to increased iron absorption. Iron accumulates in the body organs causing widespread damage. The standard treatment is iron chelation therapy and/or periodic phlebotomy to remove iron from the body; frequency of phlebotomy or chelation therapy is dependent on how quickly body iron stores accumulate.
Polyphenolic compounds are very strong inhibitors of non-heme iron absorption, as they form insoluble complexes with ferrous iron in the gastrointestinal tract that cannot be absorbed.
The investigators have recently shown in European subjects with hereditary hemochromatosis (another iron-loading disorder) that our newly-developed natural polyphenol supplement (PPS) that is rich in polyphenols, when taken with iron-rich meals or with an iron-fortified drink, reduces iron absorption by ~40%. Decreasing non-heme iron absorption in adults with iron-loading thalassemia could potentially lead to an extension of the time period between phlebotomies or chelation therapies, and therefore an improved quality of life.
Therefore, in this stable iron isotope study, the investigators will study the effect the natural PPS on oral iron absorption from an iron-rich test meal or iron-fortified drink in Thai adults with iron-loading thalassemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal with polyphenol supplement (PPS) | Experimental | Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement. |
|
| Meal with placebo | Placebo Comparator | Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin). |
|
| Drink with PPS | Experimental | Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement. |
|
| Drink with placebo | Placebo Comparator | Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal matrix with polyphenol supplement (PPS) | Dietary Supplement | Test meal with polyphenol supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in fractional iron absorption (FIA) from iron-rich test meal administered with and without the polyphenol supplement (PPS). | FIA from labelled test meals consumed with the PPS and consumed with the placebo will be determined based on the shift of the iron isotope ratios in whole blood. | Measured 14 days after administration of last test meal (study day 18 or 35) |
| Difference in FIA from iron-fortified test drink administered with and without the PPS. | FIA from labelled test drink consumed with the PPS and consumed with the placebo will be determined based on the shift of the iron isotope ratios in whole blood. | Measured 14 days after administration of last test drink (study day 18 or 35) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ferritin (µg/L) | to assess iron status | At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35) |
| Soluble transferrin receptor (mg/L) | to assess iron status |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael B Zimmermann, MD, PhD | ETH Zurich | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahidol University | Salaya | Thailand |
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| Meal matrix with placebo | Dietary Supplement | Test meal with placebo (maltodextrin) supplement |
|
| No meal matrix with PPS | Dietary Supplement | Test drink with polyphenol supplement |
|
| No meal matrix with placebo | Dietary Supplement | Test drink with placebo (maltodextrin) supplement |
|
| At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35) |
| Transferrin saturation (%) | to assess iron status | At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35) |
| Hemoglobin (g/dL) | to identify anemia and to determine blood volume | At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35) |
| C-reactive protein (mg/L) | To assess inflammation status | At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35) |
| Alpha-1-glycoprotein (g/L), | To assess inflammation status | At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35) |
| Serum hepcidin (nM) | Major regulator of non-heme iron absorption | At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35) |
| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D019190 | Iron Overload |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010426 | Pentosan Sulfuric Polyester |
| ID | Term |
|---|---|
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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