A Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.
Condition: Haematopoiesis
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: ferrous ascorbate; ferrous bisglycinate chelate 1 OD; ferrous bisglycinate chelate 2 OD
Intervention description: 100 mg elemental iron; 60 mg elemental iron; 120 mg elemental iron
Intervention MeSH terms: Ascorbic Acid; Chelating Agents; Glycine
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 271.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Iron deficiency anaemia (Haemoglobin, Hb < 12gm/dl) is one of India's major public health
      problems particularly in women. Effective control of iron deficiency anaemia decreases the
      incidence of fatigue, bodyache, headache, lack of concentration and menstrual complications.
      Iron bisglycine chelate has been used successfully to treat iron deficiency anaemia and is
      also a well tolerated therapy. Use of ferrous bisglycinate chelate one tablet daily as a
      nutritional supplement is well established in India. For treatment of iron deficiency
      anaemia, some women may need 1 tablet/day, while some may need 2 tablets/day. In India,
      ferrous ascorbate, 1 tablet daily is a widely accepted form of treatment for iron deficiency
      anaemia. The primary purpose of this study is to demonstrate the efficacy and tolerability
      profile of ferrous bisglycinate chelate to support the registration of this product as a
      'drug' in India. Comparative data between ferrous bisglycinate chelate and ferrous ascorbate
      will also augment our existing knowledge, which will further support appropriate use of
      ferrous bisglycinate chelate for the treatment of iron deficiency anaemia. Study design and
      patient population: This will be a multicentre, randomized, laboratory-blinded, parallel-
      group study. It is projected that the study will randomize 270 women (90 subjects in each
      treatment arm) with iron deficiency anaemia (Hb 6-9 gm/dl + serum Ferritin <15 μg/l) to
      either ferrous bisglycinate chelate 1 or 2 tablets/day, or ferrous ascorbate 1 tablet/day for
      8 weeks. At fortnightly visits, blood will be collected for Hb (to evaluate efficacy),
      adverse events will be documented (to evaluate tolerability), the investigational drugs will
      be dispensed and reasons for non compliance will be recorded. Study endpoints: The primary
      endpoint is defined as the rise of Hb from baseline after 8 weeks of treatment in each
      ferrous bisglycinate chelate group (1 tablet/day and 2 tablets/day). The secondary endpoints
      include the difference in the average change in Hb, difference in the rate of rise of Hb,
      difference in the proportion of patients who achieve a target Hb ≥12gm/dl and difference in
      the % incidence of gastrointestinal side effects during 8 week therapy with 2 dosing regimens
      of ferrous bisglycinate chelate (1 tablet/day and 2 tablets/day) and ferrous ascorbate 1
      tablet/day.
    

Eligibility criteria:

        Inclusion Criteria

        Subjects eligible for enrolment to the study must meet all of the following criteria:

          1. Signed and dated written informed consent is obtained prior to participation.

          2. Female outpatients between 18 to 55 years of age and using effective method of
             contraception if sexually active.

          3. Non use of any iron supplement for 3 months prior to enrolment to the study.

          4. Presence of iron deficiency anaemia: low haemoglobin (Hb 6-9 gm/dl) + low serum
             ferritin (<15 μg/l).

          5. No occult blood in stool.

          6. Able to comply with the requirements of the protocol.

          7. Subjects should have a valid telephone contact.

        Exclusion Criteria

        Subjects meeting any of the following criteria must not be enrolled to the study:

          1. Pregnancy (confirmed by urine dipstick method)

          2. Desire to conceive within the next 3 months including patients who are receiving
             treatment to facilitate conception.

          3. Lactating women.

          4. 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.).

          5. Medical history of thyroid dysfunction.

          6. Medical history of chronic renal disease.

          7. Medical history of malabsorption syndrome, haemochromatosis and haemosiderosis,
             hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy.

          8. Inability to withhold prohibited medication.

          9. Obvious internal or external bleeding as documented by medical history and/or
             examination if considered clinically significant in the opinion of the investigator.

         10. Clinically significant abnormality in laboratory reports and/or ECG.

         11. Medical history of hepatitis B, hepatitis C and/or exposure to HIV.

         12. 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.

         13. Participation in another clinical trial in the last 8 weeks before entry to Visit 0.

         14. 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.

         15. Known or suspected hypersensitivity to iron or any of the components of ferrous
             bisglycinate chelate or ferrous ascorbate tablets.