Health Condition 1: null- Diagnosed Patients of Thalassemia Major
Conditions
Interventions
Intervention1: Children were given only oral supplement, they were not taking any other chelators: The oral supplement formulation was given @50 mg/kg body wt/d ( i.e @25mg/kg body wt/d on active sa
Sponsors
Sai Chelation Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age groups:4 years to 25 years of either sex.2.Diagnosed cases of Thalassemia Major.3 children who were not taking any chelator because of cost or previous side effects 4)whose parents gave written informed consent
Exclusion criteria
Exclusion criteria: 1.Children below 4 years and above 25 years of age. 2.Cases having HIV, hepatic failure, etc. 3.Patient having BT interval for less than 10 days. 4.whose parents did not agree even after counselling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on kidney, liver and cholesterol. Change in Clotting time and transfusion interval. Iron in stool/urine. Reduction in Skin iron concentration(direct measure of body iron overload) over a time period. Calcium levels in blood plasma and excretion in 24 hr urine. Magnesium levels in blood.Zinc excretion in 24hr urine.Changes in echo cardio and abdominal sonographs.Timepoint: Patho.tests 8 times during study. sonographs and echo after 1 yr. zinc/calcium/iron exretion in 24 hr urine once,iron in stool once. skin iron concentration twice during study | — |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in sickness( increased immunity) increased appetite. Improved Skin colorationTimepoint: 1 month, 3 months ,1 yr | — |
Countries
India
Contacts
Public ContactDr NV Gandhi MS Orth
Sai Chelation Founadation
Outcome results
None listed