Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01785407
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2013-02-01
Brief Title:
Using Stable Iron Isotopic Techniques and Serum Hepcidin Profiles to Optimize Iron Supplementation
Sponsor:
Swiss Federal Institute of Technology
Organization:
Swiss Federal Institute of Technology
Study Overview
Official Title:
Using Stable Iron Isotopic Techniques and Serum Hepcidin Profiles to Optimize Iron Supplementation
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral iron supplementation OIS is a widely-used strategy to treat iron deficiency anemia However absorption of OIS is often low and response is variable To overcome this large doses are given but this may reduce compliance due to gastric irritation Thus OIS doses should be low while maximizing absorption The prevailing serum hepcidin concentration SHep is the major determinant of iron absorption and erythrocyte iron utilization Based on limited data in humans SHep can be increased by a single OIS dose but the duration of the increase is uncertain it may be in the range of 24 to 96 hr Also there are few data on how the increase in SHep determines the absorption of further doses of oral iron Is there a threshold SHep at which subsequent iron absorption is sharply reduced Better understanding of this relationship would be valuable to design more effective and safer OIS regimens
Objectives 1 Determine the duration and magnitude of the Fe induced Hepcidin rise form a single iron dose while determining its bioavailability and 2 Compare the bioavailability of a single dose to iron supplements consumed one after the other two dosages
Objectives 1 Determine the duration and magnitude of the Fe induced Hepcidin rise form a single iron dose while determining its bioavailability and 2 Compare the bioavailability of a single dose to iron supplements consumed one after the other two dosages
Detailed Description:
Background Oral iron supplementation OIS is a widely-used strategy to treat iron deficiency anemia However absorption of OIS is often low and response is variable To overcome this large doses are given but this may reduce compliance due to gastric irritation Thus OIS doses should be low while maximizing absorption The prevailing serum hepcidin concentration SHep is the major determinant of iron absorption and erythrocyte iron utilization Based on limited data in humans SHep can be increased by a single OIS dose but the duration of the increase is uncertain it may be in the range of 24 to 96 hr Also there are few data on how the increase in SHep determines the absorption of further doses of oral iron Is there a threshold SHep at which subsequent iron absorption is sharply reduced Better understanding of this relationship would be valuable to design more effective and safer OIS regimens
Objectives 1 Determine the duration and magnitude of the Fe induced Hepcidin rise form a single iron dose while determining its bioavailability and 2 Compare the bioavailability of a single dose to iron supplements consumed one after the other two dosages MethodsSubjects Healthy female subjects will be screened for low iron status Anemic subjects will be excluded from the study Thirty two subjects will be included with serum ferritin 20 µgL C-reactive protein 5 mgL and Hemoglobin 117 gL Subjects will be randomized in two groups and their Hepcidin sHep and iron status markers monitored at day 1 baseline Subjects will receive iron supplement dosages of 40 80 160 and 240 mg in either single or as two consecutive dosages with stable iron isotopes 54Fe 57Fe 58Fe in form of 4 mg of iron sulfate FeSO4 Prior administration blood samples will be collected at 800 1200 and 1600 to monitor sHep and iron status markers these measurements will be repeated on the days of supplement administration On the following days sHep will be measured at 800 to quantify the duration of the iron induced hepcidin rise In the second week subjects receiving a single Fe dose on week 1 will receive two consecutive dosages and vice versa while the same sampling scheme as in week one will be applied On day 23 a last blood sample will be collected and iron incorporation of stable isotopic labels will be measured from the different dosages administered
Outcome The combined use of stable iron isotopes and a sensitive SHep assay will allow for better understanding of the iron-hepcidin relationship and this may enable design of more effective OIS regimens
Objectives 1 Determine the duration and magnitude of the Fe induced Hepcidin rise form a single iron dose while determining its bioavailability and 2 Compare the bioavailability of a single dose to iron supplements consumed one after the other two dosages MethodsSubjects Healthy female subjects will be screened for low iron status Anemic subjects will be excluded from the study Thirty two subjects will be included with serum ferritin 20 µgL C-reactive protein 5 mgL and Hemoglobin 117 gL Subjects will be randomized in two groups and their Hepcidin sHep and iron status markers monitored at day 1 baseline Subjects will receive iron supplement dosages of 40 80 160 and 240 mg in either single or as two consecutive dosages with stable iron isotopes 54Fe 57Fe 58Fe in form of 4 mg of iron sulfate FeSO4 Prior administration blood samples will be collected at 800 1200 and 1600 to monitor sHep and iron status markers these measurements will be repeated on the days of supplement administration On the following days sHep will be measured at 800 to quantify the duration of the iron induced hepcidin rise In the second week subjects receiving a single Fe dose on week 1 will receive two consecutive dosages and vice versa while the same sampling scheme as in week one will be applied On day 23 a last blood sample will be collected and iron incorporation of stable isotopic labels will be measured from the different dosages administered
Outcome The combined use of stable iron isotopes and a sensitive SHep assay will allow for better understanding of the iron-hepcidin relationship and this may enable design of more effective OIS regimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None