Healthy Clinical Trial
| NCT number | NCT02131870 |
| Other study ID # | ProIron |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | April 30, 2014 |
| Last updated | August 13, 2014 |
| Verified date | August 2014 |
| Source | Probi AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
The purpose of this study is to study the effect of a probiotic product on iron absorption in healthy females of child-bearing age.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 19 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Female - Age =19 and =45 years - Hb >117g/L Exclusion Criteria: - Gastrointestinal diseases - Metabolic diseases - Use of other probiotic products during the study and 2 weeks before the study start - Pregnant or breast-feeding - A serum ferritin level >60 µg/L - Medication (oral contraceptives allowed) - Intake of dietary supplements (incl. iron) during the study and two weeks before the study start - No blood donation in the last 2 months - High C-reactive protein levels |
Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Department of Internal Medicin and Clinical Nutrition, the Sahlgrenska Academy, Gothenburg University | Gothenburg |
| Lead Sponsor | Collaborator |
|---|---|
| Probi AB |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Iron absorption ratio in blood samples | Iron absorption will be estimated by measuring the isotope ratio (55Fe/59Fe) in blood after addition of iron isotopes in test meals (55Fe in placebo meal, 59Fe in L plantarum DSM 9843 meal). | 14 days | No |
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