Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

Pierre Fabre

Status and phase

Completed

Phase 1

Conditions

Iron Deficiency Anemia

Treatments

Drug: Tardyferon 80 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01757119

L00008 CP 1 01

2012-002190-63 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.