Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament

Criteria

Inclusion Criteria:

• Women 18-45 years old with iron deficiency anaemia

• haemoglobin level between 85 g/L and 105 g/L

• serum ferritin level < 15 µg/L

• D14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation

• Standard diet

Exclusion Criteria:

• - Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,

• Haemochromatosis or iron overload of secondary origin (blood transfusion),

• Long term treatment known to modify iron absorption,

• Gastro duodenal ulcer,

• Inflammatory bowel disease or any digestive disease which could modify iron absorption,

• Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase,

• Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),

• Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.