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CTRI Number  CTRI/2023/01/049064 [Registered on: 17/01/2023] Trial Registered Prospectively
Last Modified On: 17/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Diet on Vitamin D deficiency in Fatty females with Non-alcoholic fatty liver disease  
Scientific Title of Study   Pilot study on effect of theraputic diet on Vitamin D deficiency in obese females with NAFLD 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kirti Bhati 
Designation  Associate Professor 
Affiliation  Bharati Vidyapeeth (Demeed to be University) College of Ayurved and Hospital 
Address  Swasthvritta evam Yoga OPD, Ground floor, Room No.15, Bharati Vidyapeeth (Deeemed to be University) College of Ayurved and Hospital Pune

Pune
MAHARASHTRA
411043
India 
Phone  9423010166  
Fax  02024365289  
Email  kirti.bhati@bharatividyapeeth.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravindra Patwardhan 
Designation  PROFESSOR 
Affiliation  Bharati Vidyapeeth (Demeed to be University) College of Ayurved and Hospital 
Address  Bharati Vidyapeeth (Deeemed to be University) College of Ayurved and Hospital Pune MAHARASHTRA
Department of Swasthavritta and Yoga Bharati Vidyapeeth (Deeemed to be University) College of Ayurved Pune MAHARASHTRA
Pune
MAHARASHTRA
411043
India 
Phone  9422522723  
Fax  02024365289  
Email  ravindra.patwardhan@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  Dr RavindraPatwardhan 
Designation  PROFESSOR 
Affiliation  Bharati Vidyapeeth (Demeed to be University) College of Ayurved and Hospital 
Address  Bharati Vidyapeeth (Deeemed to be University) College of Ayurved and Hospital Pune MAHARASHTRA
Department of Swasthavritta and Yoga Bharati Vidyapeeth (Deeemed to be University) College of Ayurved Pune MAHARASHTRA
Pune
MAHARASHTRA
411043
India 
Phone  9422522723  
Fax  02024365289  
Email  ravindra.patwardhan@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Deeemed to be University Pune MAHARASHTRA 
 
Primary Sponsor  
Name  Bharati Vidyapeeth Deeemed to be University Pune MAHARASHTRA 
Address  Bharati Vidyapeeth (Deeemed to be University Pune 411030 MAHARASHTRA 
Type of Sponsor  Research institution and hospital 
 
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 Kirti Bhati  Bharati Vidyapeeth(Deeemed to be University) College of Ayurved and Hospital  Swasthvritta evam Yoga OPD, Ground floor, Room No.15
Pune
MAHARASHTRA 
9423010166
02024365289
kirti.bhati@bharatividyapeeth.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BV(DU)COA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E559||Vitamin D deficiency, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-saMsarjana-krama (Procedure Reference: saMsarjana-krama, Procedure details: 7 day diet regimen of 3 days Manda 2 days Peya and 2 days Vilepi)
(1) Medicine Name: Uprise D, Reference: Vitamin D supplementation, Route: Oral, Dosage Form: Capsules, Dose: 60000(NA), Frequency: sos, Duration: 4 Weeks
2Comparator Arm (Non Ayurveda)-Medicine Name:Capsule Uprise D, Reference: Vitamin D supplementation, Route: Oral, Dosage Form: Capsules, Dose: 60000(IU), Frequency: once a week, Duration: 24 Weeks
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Age group 30 to 49 years and BMI ≥ 27 Kg/m2 having ≥ 1 full term delivery
Confirmed radiological diagnosis of NAFLD
Vitamin D level < 20 ng/mL (75.0 nmol/L)
Individual willing to undergo study and follow all procedures  
 
ExclusionCriteria 
Details  Known cases of T2DM

Individuals with known history of any other endocrinological disorders like Hypothyroidism, PCOS etc.

Pregnant or lactating females 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of theraputic diet in hypovitaminosis D in obese females with NAFLD.
Once recruited, all participants will undergo blood investigations viz. lipid profile (cholesterol, triglycerides, LDL & HDL), fasting blood glucose & insulin, adipokines (adiponectin & leptin). Efficacy will be assessed by difference in values of the above-mentioned lab investigations pre and post study and conclusions derived from appropriate statistical analysis 
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1) 1)To study the association between adipose tissue dysfunction and bioavailability and absorption of vitamin D. 2) To assess association between NAFLD, and hypovitaminosis D.  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and post-study follow up at 24
weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   18/01/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  NA

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report
    Response (Others) -  NA
  3. Who will be able to view these files?
    Response (Others) -  NA

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 27-11-2023 and end date provided 27-12-2025?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Over the past decade, there is growing evidence that Vitamin D deficiency has now grown into a pandemic. Prevalence of vitamin D deficiency in India is observed to be in more than 30% population, statusbeing poor in school children, pregnant women and large cities. 

 

Vitamin D is a unique vitamin as it not only can be ingested in the diet as cholecalciferol (vitamin D3) or ergocalciferol (vitamin D2) but it can also be synthesized in the skin when there is adequate sunlight exposure. The role of vitamin D was earlier restricted to skeletal diseases and bone health. Recently its many other functions have been explored and vitamin D has also been linked with several other conditions such as colorectal cancer, diabetes mellitus, multiple sclerosis, cardiovascular disease, obesity, NALFD, etc. Also, there is emerging evidence of a direct role for vitamin D in regulation of immune function. 

 

In the prevalence studies conducted for hypovitaminosis D, women have often been found to have lower levels of 25(OH)D levels than men. Hypovitaminosis D in women is of a particular concern in the childbearing age as the status of vitamin D during pregnancy in the mother is an important factor for the determination of the vitamin D status in the child. 

 

Fortification of staple foods was a strategy adopted to achieve vitamin D sufficiency but unfortunately even in advanced countries like USA and Canadathese strategies have been found to be only partially effective and have largely failed to attain vitamin D sufficiency. 

 

Among the factors that affect Vitamin D levels, the important ones are skin synthesis and dietary intake. It is interesting to note that in spite of being a deficiency disorder, its prevalence is more in obese population. Vitamin D is a fat-soluble vitamin and hence it can move into adipose tissue which can lead to a drop in serum levels. Obesity thus has effects on vitamin D bioavailability. Meta-analysis by Santos et al revealed that vitamin D deficiency was 35% higher in obese individuals. 

 

The correlation between the triad of obesity, NAFLD and hypovitaminosis D has been investigated and researched by a number of researchers. However, the role that digestion plays in vitamin D absorption, the status of liver health, quality of bile necessary for proper absorption of fat soluble nutrients like vitamin D has not yet been explored. Vitamin D absorption and its possible link to impaired fat metabolism in obesity and NAFLD could be the cause of hypovitaminosis D in obese females. With this background, the current study aims to evaluate effect of therapeutic diet in improving vitamin D levels in obese females with NAFLD. 

 
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