Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-27 @ 4:38 PM
Study NCT ID:
NCT02585661
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Bioavailability From Dairy Product
Sponsor:
Société des Produits Nestlé (SPN)
Organization:
Study Overview
Official Title:
Iron Bioavailability From Fortified Dairy Product in Healthy Women
Status:
COMPLETED
Status Verified Date:
2015-10
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:
Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds
Detailed Description:
This single center trial will be double-blind, controlled randomized with a crossover trial. One group (n=10) will start the study with the consumption of a Fe-54 salt fortified dairy product, while the other group will start the study with the consumption of Fe-57 salt fortified dairy product. The day after, in a cross over design, subjects will be administered the alternative test product. A blood sampling will be performed 14 days after the last stable isotope administration to allow the measurement of Fe stable isotope ratios and the calculation of Fe absorption. The duration of the trial will be 16 days in total.
The total sample size is 20 enrolled subjects. Patients will be healthy females aged 18-40 years old
The total sample size is 20 enrolled subjects. Patients will be healthy females aged 18-40 years old
Study Oversight
Has Oversight DMC:
False
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?: