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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E559||Vitamin D deficiency, unspecified. Ayurveda Condition: MEDOROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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 | 2 | Comparator 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
- What data in particular will be shared?
Response (Others) - NA
- What additional supporting information will be shared?
Response - Study Protocol Response - Clinical Study Report Response (Others) - NA
- Who will be able to view these files?
Response (Others) - NA
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 27-11-2023 and end date provided 27-12-2025?
Response (Others) - NIL
- 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. |