| 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
|
|
|
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
|
|
|
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. |