| CTRI Number |
CTRI/2018/01/011225 [Registered on: 10/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does treatemnt with Vitamin D and Calcium help patients with Steroid Sensitive Nephrotic Syndrome ? |
|
Scientific Title of Study
|
A Randomized Controlled Trial to assess the effect of Vitamin D deficiency and supplementation on Bone Mineral Density in steroid sensitive nephrotic syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushmita Banerjee |
| Designation |
Consultant Pediatric Nephrologist |
| Affiliation |
Institute of Child Health, Kolkata |
| Address |
Department of Pediatric Nephrology,
Institute of Child Health,
11 Biresh Guha Street,
Kolkata 700017.
Kolkata
WEST BENGAL
700017
India |
| Phone |
9830023975 |
| Fax |
|
| Email |
asban@vsnl.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushmita Banerjee |
| Designation |
Consultant Pediatric Nephrologist |
| Affiliation |
Institute of Child Health, Kolkata |
| Address |
Department of Pediatric Nephrology,
Institute of Child Health,
11 Biresh Guha Street,
Kolkata 700017.
Kolkata
WEST BENGAL
700017
India |
| Phone |
9830023975 |
| Fax |
|
| Email |
asban@vsnl.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushmita Banerjee |
| Designation |
Consultant Pediatric Nephrologist |
| Affiliation |
Institute of Child Health, Kolkata |
| Address |
Department of Pediatric Nephrology,
Institute of Child Health,
11 Biresh Guha Street,
Kolkata 700017.
Kolkata
WEST BENGAL
700017
India |
| Phone |
9830023975 |
| Fax |
|
| Email |
asban@vsnl.com |
|
|
Source of Monetary or Material Support
|
| Institute of Child Health,
11 Dr Biresh Guha Street,
Kolkata 700017 |
|
|
Primary Sponsor
|
| Name |
Institute of Child Health |
| Address |
Institute of Child Health,
11 Dr Biresh Guha Street
Kolkata 700017 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushmita Banerjee |
Institute Of Child Health |
Department of Pediatric Nephrology,
Institute of Child Health,
11 Dr Biresh Guha Street
Kolkata 700017
Kolkata
WEST BENGAL |
9830023975
asban@vsnl.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Child Health EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with Steroid Sensitive Nephrotic Syndrome in relapse at recruitment., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcium carbonate |
250 mg twice daily if 20 kg. weight or less, 500 mg twice daily of more than 20 kg. Total duration: 3 months. |
| Intervention |
Cholecalciferol (Vitamin D3) |
Vitamin D3: 60,000 units per orally weekly for 4 weeks if serum 25 hydroxycholecalciferol levels less than 30ng/ml |
| Comparator Agent |
No comparator agent. |
No comparator agent given to the control group who receive only standard NS therapy. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with diagnosed steroid sensitive nephrotic syndrome
2. Age group: 2 to 14 years
3. Consecutive patients included during active NS episode
4. Urine protein more than 2+ for 3 consecutive days and urine protein creatinine ratio > 2 at recruitment. |
|
| ExclusionCriteria |
| Details |
1. Steroid Resistant nephrotic syndrome
2. Hospitalised patients
3. Any other acute or chronic illness
4. Patients with any bone deformities or symptoms related to the musculoskeletal system
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone mineral content and density |
at recruitment and post intervention after 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nephrotic Relapse rate |
over 6 months |
| serum 25 hydroxycholecalciferol levels |
at recruitment and post intervention 6 weeks and 6 months |
| Serum calcium and urinary calcium creatinine ratio |
at recruitment and post intervention 6 weeks and 6 months |
| renal ultrasound |
after 6 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/02/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Banerjee S, Basu S, Sen A, Sengupta J. The effect of calcium and vitamin D supplementation in pediatric steroid sensitive nephrotic syndrome. Pediatric Nephrology. 2017 Nov;32(11):2063-2070. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Steroid sensitive nephrotic syndrome (NS) is a common disease affecting Indian children. The majority of affected patients have multiple relapses over many years and require repeated and long term steroid courses. Steroid toxicities like osteoporosis have been well described in this condition and may cause long term morbidity, even after the NS has resolved. Reduction in bone mineralisation has been reported to occur early, within 2 to 3 months of steroid therapy. Unfortunately in the majority of patients steroid treatment cannot be avoided.
During NS episodes, there is loss of Vitamin D binding protein along with albumin in the urine. Patients have been shown to have low levels of 25 hydroxycholecalciferol in this condition. Correction of this associated hypovitaminosis D may improve bone health in this disease and reduce degree of osteoporosis.
In addition, low Vitamin D stores have been associated with inflammatory and infective conditions. Infections are the commonest precipitants of relapses in NS. Thus correction of hypovitaminosis D may reduce relapse rates in pediatric NS.
In this RCT, patients with NS relapse are recruited, and randomised into intervention and control groups. The intervention group receives Vitamin D and calcium supplements in the attempt to optimise serum 25hydroxycholecalciferol levels. Subsequently over a 6 month period, the changes in serum 25hydroxycholecalciferol, bone mineral density and bone mineral content as well as relapse rate is analysed and compared with the control group. Monitoring is performed for any adverse effects of Vitamin D therapy, such as hypercalcemia, hypercalciuria and nephrocalcinosis.
|