Diet on Vitamin D deficiency in Fatty females with Non-alcoholic fatty liver disease

Recruiting

Conditions: Vitamin D deficiency, unspecified. Ayurveda Condition: MEDOROGAH,

Registration Number: CTRI/2023/01/049064

Lead Sponsor: Bharati Vidyapeeth Deeemed to be University Pune MAHARASHTRA

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 30

Inclusion Criteria

Age group 30 to 49 years and BMI â‰¥ 27 Kg/m2 having â‰¥ 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.

Exclusion Criteria

Known cases of T2DM Individuals with known history of any other endocrinological disorders like Hypothyroidism, PCOS etc.
Pregnant or lactating females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of theraputic diet in hypovitaminosis D in obese females with NAFLD.	Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Bharati Vidyapeeth(Deeemed to be University) College of Ayurved and Hospital
🇮🇳
Pune, MAHARASHTRA, India
Bharati Vidyapeeth(Deeemed to be University) College of Ayurved and Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Kirti Bhati
Principal investigator
9423010166
kirti.bhati@bharatividyapeeth.edu