Health Condition 1: D508- Other iron deficiency anemias
Conditions
Interventions
Intervention1: NutraXceedâ??s Modified Release Ferric pyrophosphate: Ferric pyrophosphate (soluble) equivalent to 30mg of elemental iron, 25mcg Cyanocobalamin (Vit B-12), 400mcg Folic acid
(One tablet
Sponsors
NutraXceed Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion 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 8-11.9 gm/dl) + low serum ferritin ( 5.Able to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if ANY of the following criteria apply: • 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 haematological disorders other than iron deficiency anemia, thyroid dysfunction, chronic renal disease or any other condition which may interfere with the study in the opinion of a Principal Investigator should be excluded. • 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. • 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 Ferric Pyrophosphate MR Tablets or Orofer XT tablets. • Patients with any other reason which may interfere with the study in the opinion of a Principal Investigator should be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean haemoglobin rise every 4 weeks up to 12 weeks in each Ferric Pyrophosphate MR tablets group (30 mg/day and 60mg/day tablets).Timepoint: Week 4, Week 8 ,Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean haemoglobin rise every 4 weeks up to 12 weeks in each Ferric Pyrophosphate MR tablets group (30 mg/day and 60mg/day tablets).Timepoint: week 12 | — |
Countries
India
Contacts
Public ContactDrMandar Kodgule
NutraXceed Lifesciences Pvt. Ltd
Outcome results
None listed