Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01160198 | 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. | PHASE3 | COMPLETED | 271 | — | — | Oct 13, 2010 | Feb 18, 2011 | Apr 13, 2018 | 7 | India |
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.
| Arm | Type | Description |
|---|---|---|
| ferrous bisglycinate chelate 1 OD | EXPERIMENTAL | ferrous bisglycinate chelate 1 tablet daily |
| ferrous ascorbate | ACTIVE_COMPARATOR | ferrous ascorbate, 1 tablet daily |
| ferrous bisglycinate chelate 2 OD | EXPERIMENTAL | ferrous bisglycinate chelate 2 tablets daily |
| Name | Type | Description |
|---|---|---|
| ferrous ascorbate | DRUG | 100 mg elemental iron |
| ferrous bisglycinate chelate 1 OD | DIETARY_SUPPLEMENT | 60 mg elemental iron |
| ferrous bisglycinate chelate 2 OD | DIETARY_SUPPLEMENT | 120 mg elemental iron |
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 acti...