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CTRI Number  CTRI/2024/12/077994 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 22/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assess the effect of Monthly versus daily vitamin D supplementation in children with chronic kidney disease stages 3 to 5 on vitamin d level and bone health markers 
Scientific Title of Study   Intermittent versus daily vitamin D supplementation in children with chronic kidney disease stages 3 to 5 – A Non-Inferiority Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lesa Dawman 
Designation  Associate professor 
Affiliation  PGIMER Chandigarh 
Address  Room number 5120 Block 5A Advanced Pediatric Centre PGIMER
.
Chandigarh
CHANDIGARH
160012
India 
Phone  9490752144  
Fax    
Email  lesadawman@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pujitha Vallabhaneni 
Designation  DM resident Pediatric nephrology 
Affiliation  PGIMER Chandigarh 
Address  5B APC PGIMER Chandigarh India

Chandigarh
CHANDIGARH
160012
India 
Phone  9618221731  
Fax    
Email  vallabhanenipujitha143@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lesa Dawman 
Designation  Associate professor 
Affiliation  PGIMER Chandigarh 
Address  Room no 4120 Block 4A Advanced Pediatric center PGIMER
.
Chandigarh
CHANDIGARH
160012
India 
Phone  9490752144  
Fax    
Email  lesadawman@gmail.com  
 
Source of Monetary or Material Support  
Advanced Pediatric center, PGIMER, Sector 12, Chandigarh India, Pincode 160012 
 
Primary Sponsor  
Name  Pujitha Vallabhaneni 
Address  Advanced Pediatric center PGIMER Sector 12 Chandigarh India Pincode 160012 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lesa Dawman  PGIMER  RCC clinic room number 4419, 4420, Pediatric department, Advanced Pediatric Center, Chandigarh, India, Pincode 160012
Chandigarh
CHANDIGARH 
9618221731

lesadawman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee pgimer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  daily vitamin D  Daily vitamin D supplementation 2000iu for 6 months duration 
Intervention  monthly vitamin d  monthly vitamin D 60000iu every month for 6 months duration 
 
Inclusion Criteria  
Age From  12.00 Month(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Age 1 to 14 years
CKD with eGFR less than 60ml/1.73m2/hr
Children with vitamin D levels between 12 to 50ng/ml
Patient willing to give written informed consent
 
 
ExclusionCriteria 
Details  •Vitamin D levels of more than 100ng/ml or hypercalciuria or nephrocalcinosis or hypercalcemia, or suppressed iPTH
•Not willing to come for follow-up at 3 months and 6 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Compare 25 hydroxy vitamin D levels  Baseline, 12 weeks, 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Level of serum calcium, phosphate, iPTH  Baseline, 12 weeks, 24 weeks 
Urine spot calcium creatinine ratio, USG KUB for nephrocalcinosis  baseline, 24 weeks 
Estimated GFR  Baseline, 12week, 24 weeks 
Level of BSALP TRACP-5b CTX – I   Baseline, 24 week 
Bone mineral density measured by DEXA  Baseline, 24 weeks 
 
Target Sample Size   Total Sample Size="234"
Sample Size from India="234" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="234" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2024 
Date of Study Completion (India) 01/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a single-center, open-label, randomized controlled non-inferiority trial aims to compare the efficacy and safety of monthly versus daily vitamin D supplementation in children aged 1 to 14 years with chronic kidney disease (CKD) stages 3–5. The study will recruit 234 participants with baseline serum vitamin D levels between 12–50 ng/mL and an eGFR < 60 mL/1.73 m²/hr. Participants will be randomized into two groups: one receiving monthly cholecalciferol (60,000 IU) and the other receiving daily cholecalciferol (2,000 IU) for six months. The primary objective is to compare 25-hydroxyvitamin D (25OHD) levels at 3 and 6 months. Secondary objectives include assessing serum calcium, phosphate, intact parathyroid hormone (iPTH), bone turnover markers (bone-specific alkaline phosphatase, TRACP-5b, CTX-I), and bone mineral density (BMD) via DEXA at baseline and 6 months. Routine biochemical tests, including serum electrolytes, creatinine, eGFR, and urine calcium-creatinine ratio, will also be evaluated. Participants will be monitored for compliance, adverse events, and treatment-emergent complications. With sample sizes of 117 in Group A and 117 in Group B, the study is designed to achieve 80% power to detect non-inferiority using a one-sided, two-sample t-test. The margin of non-inferiority is set at -0.100. The assumed true difference between the means is 5.500. The significance level (alpha) of the test is 0.05. The sample size was calculated from study populations with standard deviations of 18.910 and 15.130. Statistical analyses will be conducted using SPSS version 26.0. Descriptive statistics will be utilized to summarize demographic data, medical diagnoses, and clinical characteristics of the patients. Categorical variables will be expressed as frequency (percentage), while continuous variables will be presented as mean ± standard deviation (SD) or median and interquartile range (IQR) as appropriate. Associations between qualitative variables will be assessed using the chi-square test or Fisher’s exact test. The normality of continuous variables will be evaluated using the Shapiro-Wilk test, and accordingly, the Student’s t-test or Mann-Whitney U test will be applied.

 
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