| CTRI Number |
CTRI/2021/02/031591 [Registered on: 26/02/2021] Trial Registered Prospectively |
| Last Modified On: |
23/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of daily 4000 IU versus 6000 IU of oral vitamin D3 in the treatment of vitamin D deficient over weight and obese children. |
|
Scientific Title of Study
|
Comparative efficacy of daily 4000 IU versus 6000 IU of oral vitamin D3 in the treatment of vitamin D deficient overweight and obese children - A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya Setia |
| Designation |
Post graduate 1st year |
| Affiliation |
Lady Hardinge Medical College and associated hospitals |
| Address |
Doctors Duty Room, First Floor, Unit Three, Department of Pediatrics, Kalawati Saran Childrens Hospital, Lady Hardinge Medical College
Rz-1/45 B Gali Number 2 tughlakabad extension, Kalkaji.
New delhi- 110019
Delhi
Central
DELHI
110001
India |
| Phone |
7835939434 |
| Fax |
|
| Email |
priyasetia070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Singh |
| Designation |
Associate Professor in Department of Pediatrics |
| Affiliation |
Kalawati Saran Childrens Hospital |
| Address |
Room number 337 third floor Kalawati Saran Childrens Hospital
Bangla Sahib Road
Central
DELHI
110001
India |
| Phone |
9810552515 |
| Fax |
|
| Email |
drpreetisingh3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Singh |
| Designation |
Associate Professor in Department of Pediatrics |
| Affiliation |
Kalawati Saran Childrens Hospital |
| Address |
Room number 337 third floor Kalawati Saran Childrens Hospital
Bangla Sahib Road
Central
DELHI
110001
India |
| Phone |
9810552515 |
| Fax |
|
| Email |
drpreetisingh3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalawati Saran Childrens Hospital, C-604, Connaught circus, Bangla Sahib Road, New Delhi- 110001 |
|
|
Primary Sponsor
|
| Name |
Dr Priya Setia |
| Address |
Rz- 1/45 B Gali number 2 tughlakabad extension, New Delhi- 110019 |
| 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 |
| Priya Setia |
Kalawati Saran childrens Hospital |
OPD 105,106,107,108,109 First floor, Unit 1,2,3, RR in Department of Pediatrics, LHMC Bangla Sahib Road, DIZ Area, Connaught place, New Delhi- 110001
Central
DELHI |
7835939434
priyasetia070@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lady Hardinge medical college and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Vitamin D3 4000 IU |
Over weight and obese children with vitamin D levels 20ng.mL are given Oral Vitamin D3 supplement 4000 IU along with Tablet Calcium 5000 mg/day |
| Intervention |
Oral Vitamin D3 6000 IU |
Over weight and obese children with vitamin D levels 20ng.mL are given Oral Vitamin D3 supplement 6000 IU along with Tablet Calcium 5000 mg/day |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Overweight and obese defined as per Indian Academy of Pediatrics (IAP)
2.Vitamin D levels <20 ng/mL, as per global consensus recommendations, 2016 |
|
| ExclusionCriteria |
| Details |
1. Pathological obesity (syndromic, monogenic, endocrine, drug induced)
2. Already taking vitamin D or calcium supplements in the last 3 months
3. Children with underlying co-morbidity including Chronic Liver Disease (CLD), Chronic Kidney Disease (CKD), type 1 Diabetes mellitus, thyroid dysfunction or any disorder that affects bone or mineral metabolism
4. Children who are taking anti-convulsants, anti-tubercular or steroid therapy
5. Children who have undergone surgery or are immobilized for more than 1 year
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Efficacy of two treatment regimens will be assessed comparing the proportion of subjects in both the groups with:
• Normalisation of serum 25(OH) D (20-100 ng/mL)
|
three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Safety of therapy will be estimated by measuring prevalence of the following in the 2 groups of subjects at 1 and 3 months
• Hypercalcemia (11mg/dl)
• Hypercalciuria (urinary calcium to creatinine ratio 0.2 mg/gm of creatinine)
• Hypervitaminosis D (serum 25(OH) D 100 ng/ml)
2. Correlation of levels of vitamin D with HbA1c and lipid profile parameters- total cholesterol, serum triglycerides, HDL and LDL levels in both the groups.
|
Three months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3 |
|
Date of First Enrollment (India)
|
01/03/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Open Label Randomized controlled trial, parallel group comparing the efficacy of oral vitamin D3 4000 IU versus 6000 IU in vitamin D deficient ( vitamin d levels <20 ng/mL) overweight and obese children that will be conducted in India. The primary outcome is by comparing the efficacy of two treatment regimens by comparing the proportion of subjects in both the groups with normalisation of serum vitamin D levels (20-100ng/mL). Secondary outcome variable is by comparing the safety of therapy by measuring the prevalence of the followng in the 2 groups of subjects at 1 and 3 months: Hypercalcemia (>11mg/dl), Hypercalciuria (urinary calcium to creatinine
ratio >0.2 mg/gm of creatinine), Hypervitaminosis D (serum 25(OH) D >100
ng/ml). Second secondary outcome variable is to Correlate of levels of vitamin D with HbA1c
and lipid profile parameters- total cholesterol, serum triglycerides, HDL
and LDL levels in both the groups.
|