EUCTR2010-018940-15-DE
Active, not recruiting
Not Applicable
A Phase IV, multi-centre, randomized, open label study to investigate the efficacy and safety of Floradix® mit Eisen and ferro sanol® duodenal mite 50 mg in pregnant women with diagnosed iron deficiency
SALUS Haus GmbH & Co. KG0 sitesApril 9, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnant women with diagnosed iron deficiency
- Sponsor
- SALUS Haus GmbH & Co. KG
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Females who are \= 18 years old
- •2\.Confirmed singleton pregnancy
- •3\.Pregnancy at \= 23rd and \= 26th week
- •4\.Iron deficiency diagnosed before screening
- •5\.Haemoglobin \= 9,5 g/dl and \= 11,2 g/dl determined at screening
- •6\.Ferritin \< 20 µg/L determined at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Iron deficiency which is not pregnancy related
- •2\.High\-risk pregnancy
- •3\.Anaemia which is not caused by iron deficiency
- •4\.Haemochromatosis or haemosiderosis
- •5\.Myelodysplastic syndromes
- •6\.Malignancies treated with chemotherapy or radiotherapy within the last 12 months
- •7\.Gastritis or gastroduodenal ulcer
- •8\.Known serious concomitant illness: e.g. autoimmune diseases, rheumatoid arthritis, diabetes mellitus
- •9\.Known hypothyroidism
- •10\.Known hepatitis B, hepatitis C, or HIV infection
Outcomes
Primary Outcomes
Not specified
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