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| autoid | 112 |
| crg_id | CRG030600044 |
| titleoftrial | Randomized, double blind, placebo controlled trial to examine the effectiveness of zinc supplementation in reducing relapse rates in patients with steroid sensitive nephrotic syndrome |
| acronymnoftrial | |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Bagga |
| leadgivennames | Arvind |
| leadposition | Professor |
| leaddepartment | Division of Pediatric Nephrology, Pediatrics |
| leadorganisation | All India Institute of Medical Sciences |
| leadaddress | A.I.I.M.S., Ansari Nagar, New Delhi, India 110029 |
| leademail | arvindbagga@hotmail.com |
| leadphone | +91 11 26593472 |
| leadfax | +91 11 26588641 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | govt |
| otherfunding | |
| fundingnameofsponsors | All India Institute of Medical Sciences |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | yes |
| blinding_investigators | yes |
| blinding_outcomes | yes |
| blinding_analysts | yes |
| proposedstart | |
| actualstart | Oct 2004 |
| proposedcompletiondate | |
| actualcompletiondate | Jul 2006 |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | India |
| researchquestion | To determine whether zinc supplementation will decrease he frequency of relapse in subjects with frequently relapsing and infrequently relapsing steroid sensitive nephrotic syndrome |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | Steroid Sensitive Nephrotic Syndrome |
| intervention1 | Therapy with either zinc or placebo |
| intervention2 | |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | children |
| age | 1-16 years |
| totalrecruitment | 100 |
| inclusion | (1)Children aged 1-16 years with steroid responsive-frequently and in frequently relapsing nephrotic syndrome
(2)Children requiring prednisolone at doses less than 1mg/kg on alternate day to maintain remission. (3)Children with obesity (BMS >30) or short stature (height less than 2SD of the expected) requiring prednisolone at less than 0.5mg/kg on alternate days o maintain remission (4)Children who have not received zinc treatment for greater than 2 weeks in the last 3 months. (5)Children with parents willing to give informed written consent. |
| exclusion | (1)Children with known secondary nephrotic syndrome
(2)Children receiving immunosuppressive/ immunomodulative treatment other than steroid (cyclophosphamide,Levamisole, chlorambucil, cyclosporine, azathioprine) or having received such treatment during previous three months. (3)Children with known chronic disease like tuberculosis, malignancy, kalazar, hepatitis B/hepatitis C (4)Children with grade IV Protein energy malnutrition according to Indian academy of Pediatrics classification. (5)Subjects with more than one episode of life threatening complication (a)Meningitis/sepsis/peritonitis during last 6 months (b)Thrombotic events during the last 6 months (6)Glomerular filtration rate <60ml/min/1.73m2 (Schwartz formula) |
| primaryoutcomes | |
| secondaryoutcomes | |
| reference |