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CTRI Number  CTRI/2017/10/010187 [Registered on: 25/10/2017] Trial Registered Retrospectively
Last Modified On: 21/10/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the efficacy of water soluble vitamin D3 versus fat soluble vitamin D3 in vitamin D deficient adults and elderly.  
Scientific Title of Study   To evaluate the efficacy of micellized vitamin D3 versus fat soluble vitamin D3 in vitamin D deficient adults and elderly with type IV& V skin.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Sethuraman 
Designation  Professor 
Affiliation  All India Institute of Medical Science 
Address  Room no. 4068, Department of Dermatology and Venereology

New Delhi
DELHI
110029
India 
Phone  1126594369  
Fax    
Email  aiimsgsr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G Sethuraman 
Designation  Professor 
Affiliation  All India Institute of Medical Science, New Delhi 
Address  Room no 4068, Department of Dermatology and Venereology

New Delhi
DELHI
110029
India 
Phone  1126594369  
Fax  01126594369  
Email  aiimsgsr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G Sethuraman 
Designation  Professor 
Affiliation  All India Institute of Medical Science, New Delhi 
Address  Department of Dermatology and Venereology

New Delhi
DELHI
110029
India 
Phone  1126594369  
Fax    
Email  aiimsgsr@gmail.com  
 
Source of Monetary or Material Support  
International life sciences institute, New Delhi, India 
 
Primary Sponsor  
Name  International Life Sciences Institute India 
Address  International Life Sciences Institute (India), G 7 Lajpat Nagar III New Delhi 110024  
Type of Sponsor  Other [Non-profitable Non-governmental Organization] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Sethuraman  All India Institute of Medical Sciences  Room no. 4068, Department of Dermatology
New Delhi
DELHI 		 01126594369

aiimsgsr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Vitamin D deficient adults,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None  None 
Intervention  Vitamin D supplementation  Two hundred healthy adults (100 males and 100 females) and 200 healthy (100 males and 100 females) elderly individuals females), with vitamin D deficiency ( serum 25 (OH) D less than 20 ng/mL) will be supplemented with vitamin D3 60000 IU every month in a randomized manner with either micellized or fat soluble form for a period of 12 months . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adults and elderly with vitamin D deficiency 
 
ExclusionCriteria 
Details  1. Subjects suffering from any systemic
disorders affecting the bone mineral health.
2. Adults and elderly consuming calcium,
vitamin D or other medications like ATT,
anticonvulsants etc, which are likely to
impact bone mineral metabolism. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of micellized vitamin D3 versus
fat soluble vitamin D3 in adults and elderly with known
vitamin D deficiency 		 After 6 and 12 months of supplementation 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of vitamin D3 supplementation on bone markers
(PINP, NTX) and inflammatory markers (ultrasensitive
C-reactive protein, tumour necrosis factor-α, interleukin-
6 and interferon-γ) 		 After 6 and 12 months of supplementation 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/10/2016 
Date of Study Completion (India) 20/02/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In this randomized prospective study, we aim to evaluate the efficacy of micellized vitamin D over non-micellized Vitamin D in adults and elderly. Two hundred healthy adults (100 males and 100 females) and 200 healthy (100 males and 100 females) elderly individuals females), with vitamin D deficiency ( serum 25 (OH) D < 20 ng/mL) will be included in this study. A thorough history will be taken followed by a detailed clinical and systemic examination. Vitamin D3 supplementation will be given 60000 IU every month in a randomized manner with either micellized or non-micellized of vitamin D3 for a period of 12 months . Blood samples will be collected at baseline and after 6 & 12 months of supplementation. The samples will be analyzed for serum 25(OH) D, parathyroid hormone (PTH), calcium, phosphates, alkaline phosphatase, bone markers (serum PINP & CTX) and inflammatory markers (IL-1, 2, 6 and 10, IFN- γ, ultrasensitive CRP & TNF-α). Urine samples collected at baseline and after 6 & 12 months of supplementation with oral cholecalciferol, were analyzed for calcium creatinine ratio.

Results:

Eighty-nine subjects in group A and 77 in group B completed the trial. Subjects in both  groups had  significant increase in their serum 25(OH)D levels following supplementation (Group A: 8.6 ± 4.4 ng/mL to 30.7 ± 7.5 ng/mL (p < 0.001); Group B: 9.1 ± 4.1 to 23.1 ± 6.4 ng/mL (p < 0.001). Participants in micellized group had an additional increase of 8.1 ng/mL in serum 25(OH)D levels (p<0.001). Eighty one  (91%) subjects in group A and fifty two (67%) in group B achieved serum 25(OH)D >20ng/ml (p <0.0001) following supplementation. No hypercalcemia or hypercalciurea was noted during the trial.

Conclusion:

Supplementation with both micellized and non-micellized vitamin D3 result in a significant rise in serum 25(OH)D levels. Micellized vitamin D3 appears to be more efficacious.

 

 

 
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