Iron Deficiency Anemia
Conditions
Keywords
Ferrous (II) Glycine Sulphate Complex, Polyferose, Ferro Sanol duodenal, Niferex, Iron Deficiency Anemia
Brief summary
To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron Deficiency Anemia.
Interventions
DRUGFerrous (II) Glycine Sulphate Complex
Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks). Administered orally with water.
DRUGPolyferose
Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks). Administered orally with water.
OTHERPlacebo to Ferrous (II) Glycine Sulphate Complex
Administered orally with water.
OTHERPlacebo to Polyferose
Administered orally with water.
Sponsors
Sanol GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* An iron deficiency anemia patient with Serum Ferritin \< 12 ng/mL, serum Hb-values \>60 and \< 120 g/L in males, \< 110 g/L in females
Exclusion criteria
* With any Mal-absorption Syndrome * With a history of Thalassemia or Sickle Cell Anemia * With untreated concurrent Vitamin B12 or Folate deficiency at Baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 | From Baseline to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2 | From Baseline to Week 2 | — |
| Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4 | From Baseline to Week 4 | — |
| Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8 | From Baseline to Week 8 | — |
| Percentage of Responders at Week 12 | End of Treatment Period (Week 12) | Responders are defined as having an increment of Hemoglobin (Hb) \> 15 g/L and post-treatment Hb \> 120 g/L (male) or \> 110 g/L (female) at Visit 6 (Week 12). |
Countries
China
Participant flow
Recruitment details
This multicenter study started to enroll subjects in March 2011 in order to end up with 16 centers in China with enrolled subjects.
Pre-assignment details
Participant Flow refers to the Randomized Set (RS). The RS includes all subjects who have a randomization number recorded on the Case Report Form (CRF).
Participants by arm
| Arm | Count |
|---|---|
| Ferrous (II) Glycine Sulphate Complex Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Polyferose: Administered orally with water. | 122 |
| Polyferose Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water. | 116 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 7 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Protocol Violation | 2 | 2 |
| Overall Study | Unknown Reason | 4 | 7 |
| Overall Study | Withdrawal by Subject | 7 | 5 |
Baseline characteristics
| Characteristic | Ferrous (II) Glycine Sulphate Complex | Polyferose | Total |
|---|---|---|---|
| Age, Continuous | 37.2 years STANDARD_DEVIATION 8.5 | 37.8 years STANDARD_DEVIATION 7.9 | 37.5 years STANDARD_DEVIATION 8.2 |
| Height | 161.2 centimeter (cm) STANDARD_DEVIATION 4.4 | 161.2 centimeter (cm) STANDARD_DEVIATION 4.6 | 161.2 centimeter (cm) STANDARD_DEVIATION 4.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 122 Participants | 116 Participants | 238 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 122 participants | 116 participants | 238 participants |
| Sex: Female, Male Female | 122 Participants | 115 Participants | 237 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
| Weight | 58.2 kilogram (kg) STANDARD_DEVIATION 7.8 | 58.1 kilogram (kg) STANDARD_DEVIATION 7.6 | 58.1 kilogram (kg) STANDARD_DEVIATION 7.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 126 | 25 / 122 |
| serious Total, serious adverse events | 3 / 126 | 3 / 122 |
Outcome results
Primary
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
Time frame: From Baseline to Week 12
Population: The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferrous (II) Glycine Sulphate Complex | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 | 31.47 gramm per liter (g/L) | Standard Deviation 23.77 |
| Polyferose | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 | 31.92 gramm per liter (g/L) | Standard Deviation 21.82 |
95% CI: [-8.47, 4.09]
Secondary
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
Time frame: From Baseline to Week 2
Population: The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferrous (II) Glycine Sulphate Complex | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2 | 12.29 gramm per liter (g/L) | Standard Deviation 13.6 |
| Polyferose | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2 | 12.79 gramm per liter (g/L) | Standard Deviation 13.13 |
Secondary
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
Time frame: From Baseline to Week 4
Population: The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferrous (II) Glycine Sulphate Complex | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4 | 20.37 gramm per liter (g/L) | Standard Deviation 19.63 |
| Polyferose | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4 | 20.16 gramm per liter (g/L) | Standard Deviation 17.46 |
Secondary
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
Time frame: From Baseline to Week 8
Population: The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferrous (II) Glycine Sulphate Complex | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8 | 26.57 gramm per liter (g/L) | Standard Deviation 22.67 |
| Polyferose | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8 | 28.33 gramm per liter (g/L) | Standard Deviation 20.9 |
Secondary
Percentage of Responders at Week 12
Responders are defined as having an increment of Hemoglobin (Hb) \> 15 g/L and post-treatment Hb \> 120 g/L (male) or \> 110 g/L (female) at Visit 6 (Week 12).
Time frame: End of Treatment Period (Week 12)
Population: The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferrous (II) Glycine Sulphate Complex | Percentage of Responders at Week 12 | 71.6 percentage of participants |
| Polyferose | Percentage of Responders at Week 12 | 80.4 percentage of participants |