HaematopoiesisPhase 3NCT01160198
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.
A Phase 3 study testing ferrous ascorbate, ferrous bisglycinate chelate 1 OD and ferrous bisglycinate chelate 2 OD in people with Haematopoiesis, run by GlaxoSmithKline at 7 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Haematopoiesis
- What is being tested?
- ferrous ascorbate, ferrous bisglycinate chelate 1 OD and ferrous bisglycinate chelate 2 OD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 7 sitesIndia
- Study dates
- 13 Oct 2010to 18 Feb 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
GSK Investigational Site
Bhojipura, Bareilly, 243202
GSK Investigational Site
Lucknow, 226003
GSK Investigational Site
Lucknow, 226017
GSK Investigational Site
Nagpur, 440022
GSK Investigational Site
Pune, 411 001
GSK Investigational Site
Surat, 395002
GSK Investigational Site
Thane,Mumbai, 400605
About this study
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.
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.
Read the 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 manifestation of iron deficiency. IDA is a consequence of decreased iron intake, increased iron loss from the body or increased iron requirements Blood loss during menstruation can predispose women to have poor iron stores and the presence of excess menstrual bleeding can contribute to the development of IDA in women. Patients with IDA usually present with fatigue, headache, bodyache, paraesthesia and lack of concentration. IDA can cause menorrhagia, which in turn can aggravate IDA. With severe anemia, there may be amenorrhoea as well.
Iron deficiency anaemia is often treated with iron tablets such as ferrous sulphate, ferrous fumarate and ferrous gluconate. It usually takes about 6-10 weeks for Hb to return to normal after initiation of oral iron therapy. Although efficacious from a haematological point of view, most of these therapies are associated with limiting gastrointestinal side effects (e.g. nausea, vomiting, constipation, diarrhoea and abdominal pain), which eventually reduce patient compliance.
Among the recent alternatives, iron bisglycine chelate has been used successfully to treat iron deficiency anaemia and is also a well tolerated therapy.
Use of ferrous bisglycinate chelate (each tablet contains 60mg of elemental iron as ferrous bisglycinate chelate, 1 mg folic acid, 5 mcg cyanocobalamin and 15 mg zinc bis-glycinate), 1 tablet daily is well established as a nutritional supplement in India. However, for treatment of iron deficiency anaemia, some women may need 1 tablet/day, while some may need 2 tablets /day.
In India, ferrous ascorbate tablets (each tablet contains 100 mg elemental iron as ferrous ascorbate, with 1 mg folic acid) in the recommended dose of 1 tablet daily are 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 the use of ferrous bisglycinate chelate for the treatment of iron deficiency anaemia.
Objective(s)
Primary:
To estimate the mean rise in haemoglobin level in patients with iron deficiency anaemia after 8 weeks of treatment (vs. baseline) with ferrous bisglycinate chelate (1 tablet and 2 tablets daily).
Secondary:
- To compare the mean rise in haemoglobin in patients with iron deficiency anaemia after 8 weeks treatment with ferrous bisglycinate chelate, 1 tablet and 2 tablets daily vs. ferrous ascorbate 1 tablet daily.
- 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.
- To compare the 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.
- 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.
Study Design 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 tablet/day, ferrous bisglycinate chelate 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.
The total study duration consists of an 8-week treatment period and will involve 6 clinic visits.
Study Endpoints/Assessments Primary Endpoint(s) Rise of haemoglobin from baseline to 8 weeks in each ferrous bisglycinate chelate group (1 tablet daily and 2 tablets daily).
Secondary Endpoint(s)
- 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.
- 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.
- 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.
- 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.
- Conditions
- Haematopoiesis
- Being tested
- ferrous ascorbate, ferrous bisglycinate chelate 1 OD, ferrous bisglycinate chelate 2 OD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous ascorbateDrug
100 mg elemental iron
ferrous bisglycinate chelate 1 ODDietary supplement
60 mg elemental iron
ferrous bisglycinate chelate 2 ODDietary supplement
120 mg elemental iron
| Study group | Role | What they receive |
|---|---|---|
| ferrous bisglycinate chelate 1 OD | Experimental | ferrous bisglycinate chelate 1 tablet daily Receives: Dietary Supplement: ferrous bisglycinate chelate 1 OD |
| ferrous ascorbate | Active comparator | ferrous ascorbate, 1 tablet daily Receives: Drug: ferrous ascorbate |
| ferrous bisglycinate chelate 2 OD | Experimental | ferrous bisglycinate chelate 2 tablets daily Receives: Dietary Supplement: ferrous bisglycinate chelate 2 OD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin (Hb) After 8 Weeks of Treatment in Each Ferrous Bisglycinate Chelate Group (1 Tablet Daily and 2 Tablets Daily)
At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Measured: Baseline and Week 8
Secondary outcomes (4)
Mean Change in Hb From Baseline to 8 Weeks
At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Measured: Baseline to Week 8
Percentage of Participants Who Achieved a Target Hb More Than or Equal to 12 gm/dL After 8 Weeks of Treatment
At fortnightly visits, blood was collected for Hb. Number of participants who achieved a target Hb of more than or equal to 12 gm/dL is presented.
Measured: Up to Week 8
Mean Change in Hb During 8 Weeks Therapy
At fortnightly visits, blood was collected for Hb. Mean change in Hb at Week 2, Week 4, Week 6 and Week 8 are presented.
Measured: Up to Week 8
Difference in Percentage of Participants With Gastrointestinal Side Effects During 8 Weeks Treatment With Ferrous Bisglycinate Chelate and Ferrous Ascorbate
The comparison in percentage of participants with gastrointestinal side effects during 8 week treatment period is reported. Gastrointestinal side effects during 8 weeks treatment included abdominal discomfort, gastritis, nausea, dyspepsia, change in bowel habit, constipation, faeces discolored, diarrhea and flatulence.
Measured: Up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study start13 Oct 2010
- Primary completion18 Feb 2011
- Study completion18 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HaematopoiesisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160198
- Sponsor's protocol ID
- 114204
- Status last verified
- Sep 2017
- First submitted
- 1 Jul 2010
- Last updated
- 13 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01160198
- Acronym / sponsor ID
- 114204
- Conditions
- Haematopoiesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2010 (actual)
- Primary completion
- 18 Feb 2011 (actual)
- Study completion
- 18 Feb 2011 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Posted 13 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 manifestation of iron deficiency. IDA is a consequence of decreased iron intake, increased iron loss from the body or increased iron requirements Blood loss during menstruation can predispose women to have poor iron stores and the presence of excess menstrual bleeding can contribute to the development of IDA in women. Patients with IDA usually present with fatigue, headache, bodyache, paraesthesia and lack of concentration. IDA can cause menorrhagia, which in turn can aggravate IDA. With severe anemia, there may be amenorrhoea as well.
Iron deficiency anaemia is often treated with iron tablets such as ferrous sulphate, ferrous fumarate and ferrous gluconate. It usually takes about 6-10 weeks for Hb to return to normal after initiation of oral iron therapy. Although efficacious from a haematological point of view, most of these therapies are associated with limiting gastrointestinal side effects (e.g. nausea, vomiting, constipation, diarrhoea and abdominal pain), which eventually reduce patient compliance.
Among the recent alternatives, iron bisglycine chelate has been used successfully to treat iron deficiency anaemia and is also a well tolerated therapy.
Use of ferrous bisglycinate chelate (each tablet contains 60mg of elemental iron as ferrous bisglycinate chelate, 1 mg folic acid, 5 mcg cyanocobalamin and 15 mg zinc bis-glycinate), 1 tablet daily is well established as a nutritional supplement in India. However, for treatment of iron deficiency anaemia, some women may need 1 tablet/day, while some may need 2 tablets /day.
In India, ferrous ascorbate tablets (each tablet contains 100 mg elemental iron as ferrous ascorbate, with 1 mg folic acid) in the recommended dose of 1 tablet daily are 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 the use of ferrous bisglycinate chelate for the treatment of iron deficiency anaemia.
Objective(s)
Primary:
To estimate the mean rise in haemoglobin level in patients with iron deficiency anaemia after 8 weeks of treatment (vs. baseline) with ferrous bisglycinate chelate (1 tablet and 2 tablets daily).
Secondary:
- To compare the mean rise in haemoglobin in patients with iron deficiency anaemia after 8 weeks treatment with ferrous bisglycinate chelate, 1 tablet and 2 tablets daily vs. ferrous ascorbate 1 tablet daily.
- 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.
- To compare the 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.
- 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.
Study Design 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 tablet/day, ferrous bisglycinate chelate 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.
The total study duration consists of an 8-week treatment period and will involve 6 clinic visits.
Study Endpoints/Assessments Primary Endpoint(s) Rise of haemoglobin from baseline to 8 weeks in each ferrous bisglycinate chelate group (1 tablet daily and 2 tablets daily).
Secondary Endpoint(s)
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ferrous bisglycinate chelate 1 OD | Experimental | Dietary Supplement: ferrous bisglycinate chelate 1 ODferrous bisglycinate chelate 1 tablet daily |
| ferrous ascorbate | Active comparator | Drug: ferrous ascorbateferrous ascorbate, 1 tablet daily |
| ferrous bisglycinate chelate 2 OD | Experimental | Dietary Supplement: ferrous bisglycinate chelate 2 ODferrous bisglycinate chelate 2 tablets daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferrous ascorbate100 mg elemental iron | Drug | ferrous ascorbate |
| ferrous bisglycinate chelate 1 OD60 mg elemental iron | Dietary supplement | ferrous bisglycinate chelate 1 OD |
| ferrous bisglycinate chelate 2 OD120 mg elemental iron | Dietary supplement | ferrous bisglycinate chelate 2 OD |
Primary outcome
Change From Baseline in Hemoglobin (Hb) After 8 Weeks of Treatment in Each Ferrous Bisglycinate Chelate Group (1 Tablet Daily and 2 Tablets Daily)
Time frame: Baseline and Week 8
At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
4 secondary outcomes
Mean Change in Hb From Baseline to 8 Weeks
Time frame: Baseline to Week 8
Percentage of Participants Who Achieved a Target Hb More Than or Equal to 12 gm/dL After 8 Weeks of Treatment
Time frame: Up to Week 8
Mean Change in Hb During 8 Weeks Therapy
Time frame: Up to Week 8
Difference in Percentage of Participants With Gastrointestinal Side Effects During 8 Weeks Treatment With Ferrous Bisglycinate Chelate and Ferrous Ascorbate
Time frame: Up to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Haematopoiesis
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Not yet recruitingPhase 2
Modulation of Stem Cell Differentiation in Individuals With High Risk Clonal Haematopoiesis
Clonal Cytopenia of Uncertain Significance, CCUS Clonal Cytopenia of Undetermined Significance
RecruitingPhase 2
Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
Vascular Inflammation, ASCVD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ferrous ascorbate, ferrous bisglycinate chelate 1 OD and ferrous bisglycinate chelate 2 OD in people with Haematopoiesis, run by GlaxoSmithKline at 7 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin (Hb) After 8 Weeks of Treatment in Each Ferrous Bisglycinate Chelate Group (1 Tablet Daily and 2 Tablets Daily) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.