Erva-mate influence on iron absorption from the diet in people with hereditary iron overload

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2018
INTERVENTION: All participants will receive all treatments: Ilex paraguariensis infusion, water and silybum marianum suspension and in random order. This is a crossover study and will be with 12 participants. Intervention group: The participants are 12 patients with Hereditary Hemochromatosis. They will be ingesting a standardized meal containing, 11.4 mg non‐haem iron (1.4 endogenous and 10 mg added in the form of ferrous sulfate) and with the treatment for the intervention group: 200 mL Ilex paraguariensis (erva‐mate) leave infusion. The infusion will be prepared in proportion of 100 mg/mL and 10 min of infusion. Negative control group: The participants are 12 patients with Hereditary Hemochromatosis. They will be ingesting a standardized meal containing, 11.4 mg non‐haem iron (1.4 endogenous and 10 mg added in the form of ferrous sulfate) and with the treatment for the negative control group, 200 mL water. Positive control group or silybum marianum group: The participants are 12 patients with hereditary hemochromatosis. They will be ingesting a standardized meal containing, 11.4 mg non‐haem iron (1.4 endogenous and 10 mg added in the form of ferrous sulfate) and with the treatment for the silybum marianum group: 200 mL water and silybum marianum commercial suspension with 140 mg in the form of silybin. Silybum marianum just has already been studied to reduce iron absortion. After an overnight fast, bold will be taken immediately before and at 1, 2, 3 and 4 hous after ingestion of the standardized meal with the treatment (Ilex paraguariensis infusion, water or silybum marianum suspension). The patients will participate three morning at same hour (between 08:00 – 08:30 hours) after fasting overnight with an interval of seven days between each test (treatment). Dietary supplement Genetics SP6.051.227 CONDITION: C16.320.565.618.337 disorders of iron metabolism; hemochromatosis ; E83.1 ; C16.320.565.618.337 E00‐E90 PRIMARY OUTCOME: The appearence and clearence of total serum iron will be assessed by calculating the area under the serum iron curve over the 4 hours observation period.; The area under the serum iron curve will be calculated using the trapezium rule by the statistic software GraphPad Prism 6.0; ; The area under the curve is constructed with the results for the concentration of serum iron in micromol per liter as a function of the time in hours. Samples of blood collected at time zero and after 1, 2, 3 and 4 hours.; ; The expected result is to demonstrate whether the consumption of Ilex paraguariensis (erva mate) can decrease the absorption of iron meal in patients with hereditary hemochromatosis. Thus, to contribute with perspectives related to the adjuvant treatment of hereditary hemochromatosis, with the search for natural chelating compounds, which may reduce the absorption of dietary iron in the patients. SECONDARY OUTCOME: Secondary outcomes are not expected. INCLUSION CRITERIA: hereditary hemochromatosis; live in Florianópolis, State of Santa Catarina Brazil; a minimum age limit of 18 years; maintenance treatment; homozygous for the C282Y mutation in HFE; absence of anemia and a minimum interval of one month from the last phlebotomy.
Epistemonikos ID: 58e07c6ad7497f5d209573034c7d1170e29e1f4f
First added on: Aug 24, 2024