Status:
COMPLETED
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.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haematopoiesis
Eligibility:
FEMALE
18-55 years
Phase:
PHASE3
Brief 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 fatig...
Detailed Description
Rationale Iron deficiency is the most common form of malnutrition globally. In India, nearly 70% of women are estimated to be iron deficient. Iron deficiency anemia (IDA, Hb \<12gm/dl) is a very late ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects eligible for enrolment to the study must meet all of the following 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
- Subjects meeting any of the following criteria must not be enrolled to the study:
- 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 ferrous bisglycinate chelate or ferrous ascorbate tablets.
Exclusion
Key Trial Info
Start Date :
October 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2011
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT01160198
Start Date
October 13 2010
End Date
February 18 2011
Last Update
April 13 2018
Active Locations (7)
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1
GSK Investigational Site
Bhojipura, Bareilly, India, 243202
2
GSK Investigational Site
Lucknow, India, 226003
3
GSK Investigational Site
Lucknow, India, 226017
4
GSK Investigational Site
Nagpur, India, 440022