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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01160198
First received: July 1, 2010
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Haematopoiesis
Anaemia
Drug: ferrous ascorbate
Dietary Supplement: ferrous bisglycinate chelate 1 OD
Dietary Supplement: ferrous bisglycinate chelate 2 OD
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Multicentre, Randomized, Laboratory-blinded, Parallel-group Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Rise of haemoglobin from baseline to 8 weeks in each ferrous bisglycinate chelate group (1 tablet daily and 2 tablets daily). [ Time Frame: baseline, 8 weeks ]

Secondary Outcome Measures:
  • The difference in the average change in Hb from baseline to 8 weeks with ferrous bisglycinate chelate 1 and 2 tablets daily, and ferrous ascorbate 1 tablet daily. [ Time Frame: 8 weeks ]
  • The difference in the average rate of rise of Hb during 8 weeks of treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily, and ferrous ascorbate 1 tablet daily [ Time Frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks ]
  • The difference in proportion of patients who achieve a target Hb ≥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. [ Time Frame: 8 weeks ]
  • The difference in % 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. [ Time Frame: 8 weeks ]

Enrollment: 271
Study Start Date: October 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ferrous bisglycinate chelate 1 OD
ferrous bisglycinate chelate 1 tablet daily
Dietary Supplement: ferrous bisglycinate chelate 1 OD
60 mg elemental iron
Active Comparator: ferrous ascorbate
ferrous ascorbate, 1 tablet daily
Drug: ferrous ascorbate
100 mg elemental iron
Experimental: ferrous bisglycinate chelate 2 OD
ferrous bisglycinate chelate 2 tablets daily
Dietary Supplement: ferrous bisglycinate chelate 2 OD
120 mg elemental iron

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160198

Locations
India
GSK Investigational Site
Bhojipura, Bareilly, India, 243202
GSK Investigational Site
Lucknow, India, 226017
GSK Investigational Site
Lucknow, India, 226003
GSK Investigational Site
Nagpur, India, 440022
GSK Investigational Site
Pune, India, 411 001
GSK Investigational Site
Surat, India, 395002
GSK Investigational Site
Thane,Mumbai, India, 400605
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01160198     History of Changes
Other Study ID Numbers: 114204
Study First Received: July 1, 2010
Last Updated: March 29, 2012
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ascorbic Acid
Glycine
Antioxidants
Glycine Agents
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014