Health Condition 1: null- Iron Deficiency Anaemia
Conditions
Interventions
Intervention1: Ferronine: 60 mg OD for 2 months
Intervention2: Ferronine: 60 mg OD for 2 months
Intervention3: Ferronine: 60 mg BD [twice daily] for 2 months
Control Intervention1: Orofer XT: 100 mg O
Sponsors
GlaxoSmithKline Pharmaceuticals LtdAddress AB Road Worli Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: Signed and dated written informed consent is obtained prior to participation. Female outpatients between 18 to 55 years of age and using effective method of contraception if sexually active. Non use of any iron supplement for 3 months prior to enrolment to the study. Presence of iron deficiency anaemia: low haemoglobin (Hb 6-9 gm/dl) + low serum ferritin (15 μg/l). No occult blood in stool. Able to comply with the requirements of the protocol. Subjects should have a valid telephone contact.
Exclusion criteria
Exclusion criteria: Pregnancy (confirmed by urine dipstick method) Desire to conceive within the next 3 months including patients who are receiving treatment to facilitate conception. Lactating women. Medical history of current hematological disorders other than iron deficiency anaemia (e.g. aplastic anaemia, megaloblastic anaemia, sideroblastic anaemia, pernicious anaemia, thalassemia, sickle cell anaemia, etc.). Medical history of thyroid dysfunction. Medical history of chronic renal disease. Medical history of malabsorption syndrome, haemochromatosis and haemosiderosis, hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy. Inability to withhold prohibited medication. Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator. Clinically significant abnormality in laboratory reports and/or ECG. Medical history of hepatitis B, hepatitis C and/or exposure to HIV. Serious, uncontrolled disease (other than thyroid dysfunction and chronic renal disease) including serious psychological disorders likely to interfere with the study and/or likely to cause death within the study period. Participation in another clinical trial in the last 8 weeks before entry to Visit 0. Evidence of alcohol or drug abuse, that may, in the opinion of the investigator interfere with study compliance or prevent understanding of the objectives, investigational procedures or possible consequences of the study. Known or suspected hypersensitivity to iron or any of the components of Ferronine or Orofer XT tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Hemoglobin Rise in each ferrous bisglycinate chelate group (1 tablet daily and 2 tablets daily).Timepoint: every 2 Weeks upto 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Haemoglobin at 8 weeks in each ferrous bisglycinate chelate group (ferrous bisglycinate chelate 1 and 2 tablets daily) and in the ferrous ascorbate group (1 tablet daily). 2. Haemoglobin at 2 weeks, 4 weeks, 6 weeks and 8 weeks in each ferrous bisglycinate chelate group (ferrous bisglycinate chelate 1 and 2 tablets daily) and in the ferrous ascorbate group (1 tablet daily). 3. The proportion of patients who achieve a target Hb ≥11gm/dl at 8 weeks in each ferrous bisglycinate chelate group (ferrous bisglycinate chelate 1 tablet and 2 tablets daily) and in the ferrous ascorbate group (1 tablet daily). Timepoint: 8 Weeks;2. To compare the average rate of rise of haemoglobin during 8 weeks of treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily and ferrous ascorbate 1 tablet daily.Timepoint: 8 weeks;3. To compare the proportion of patients who achieve a target Hb â?¥ 12gm/dl after 8 weeks of treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily and ferrous ascorbate 1 tablet daily.Timepoint: 8 weeks;4. To compare the % incidence of gastrointestinal side effects during 8 weeks treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily and ferrous ascorbate 1 tablet daily.Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactRodabeh Vania
Medical Affairs Department
Outcome results
None listed