Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

Phase 1

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: Tardyferon 80 mg

• Registration Number: NCT01757119
• Lead Sponsor: Pierre Fabre Medicament

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-28
• Study Start: 2013-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug	Tardyferon 80 mg	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement	Up to 24 hours	Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement by measuring Maximum Plasma concentration, Time of Maximum Concentration, Area under the iron plasma concentration curve.

Secondary Outcome Measures

Name	Time	Method
Tolerability of single administration (reported adverse events)	Up to 24 hours	Tolerability by evaluating the number of subjects with emergent adverse events