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Completed

NCT Number: NCT01757119

Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Iași, Romania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tardyferon 80 mg

Drug

Oral administration (2 tablets)

Primary outcomes

  1. Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement

    Time frame: 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 outcomes

  1. Tolerability of single administration (reported adverse events)

    Time frame: Up to 24 hours

    Tolerability by evaluating the number of subjects with emergent adverse events

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 28, 2012
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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