Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Iron Deficiency Anaemia as 7 less than or equal to Hb less than 10 g dl Ability and willingness to comply with the study protocol Informed Consent given by parent or guardian
Exclusion criteria
Exclusion criteria: Iron deficiency likely or definitely due to blood loss History or evidence of intestinal malabsorption History of prior intravenous iron therapy Major co morbidity such as diarrhoea or a srious chronic medical condition unrelated to iron deficiency apparent on history physical examination High likelihood of suboptimal adherence by parents with study requirements Inability to tolerate oral medications History of birth at less than 30 weeks gestation Other medical or social factors at discretion of treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in haemoglobin levels in subjects from baseline in the paediatric subjects of 2 to 7 years of age at the end of 8th weekTimepoint: Increase in haemoglobin levels in subjects from baseline in the paediatric subjects of 2 to 7 years of age at the end of 8th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and Percentage of patients with treatment emergent adverse events Compliance check with investigational productTimepoint: Secondary outcome will be assessed or estimated at baseline 4 weeks and 8 weeks | — |
Countries
India
Contacts
Childrens Clinic and Vaccination Centre