Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

Iron Deficiency Anemia Clinical Trial

Official title:

Study of the Pharmacokinetics of Serum Iron After Single Oral Administration of Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757119
• Other study ID #: L00008 CP 1 01
• Secondary ID: 2012-002190-63
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2012
• Last updated: April 14, 2014
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics CommitteeRomania: National Agency for Medicines and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Tardyferon 80 mg
Oral administration (2 tablets)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement	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.	Up to 24 hours	No
Secondary	Tolerability of single administration (reported adverse events)	Tolerability by evaluating the number of subjects with emergent adverse events	Up to 24 hours	Yes