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CTRI Number  CTRI/2025/12/099380 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   We will analyse how many people who have cancer also have low levels of vitamin D in their body as they visit to Palliative Medicine Outpatient Department. 
Scientific Title of Study   Retrospective audit to identify the Vitamin D deficiency in cancer patients attending in Palliative Medicine Department 
Trial Acronym  Vitamin D and cancer pain 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SOMNATH DEY 
Designation  Associate Professor 
Affiliation  MPMMCC and HBCH Tata Memorial Centre Varanasi  
Address  Department of Pain and Palliative Medicine Mahamana Pandit Madan Mohan Malvia Cancer Centre Sunderpur Campus Private OPD Room No 41 Ground Floor Sundar Bagiya Nariya Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  07595802711  
Fax    
Email  drdeysomnath@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  SOMNATH DEY 
Designation  Associate Professor 
Affiliation  MPMMCC and HBCH Tata Memorial Centre Varanasi  
Address  Department of Pain and Palliative Medicine Mahamana Pandit Madan Mohan Malvia Cancer Centre Sunderpur Campus Private OPD Room No 41 Ground Floor Sundar Bagiya Nariya Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  07595802711  
Fax    
Email  drdeysomnath@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  SOMNATH DEY 
Designation  Associate Professor 
Affiliation  MPMMCC and HBCH Tata Memorial Centre Varanasi  
Address  Department of Pain and Palliative Medicine Mahamana Pandit Madan Mohan Malvia Cancer Centre Sunderpur Campus Private OPD Room No 41 Ground Floor Sundar Bagiya Nariya Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  07595802711  
Fax    
Email  drdeysomnath@yahoo.co.in  
 
Source of Monetary or Material Support  
MPMMCC and HBCH, Varanasi, Units of Tata Memorial Centre, Mumbai, Department of Atomic Energy, Govt. of India. Department of Pain and Palliative Medicine. Banaras Hindu University, Campus, Sundar Bagiya Colony, Sundarpur, Varanasi, Uttar Pradesh. India Pin- 221005 
 
Primary Sponsor  
Name  MPMMCC and HBCH Varanasi UP India 
Address  Department of Pain and Palliative Medicine. Mahamana Pandit Madan Mohan Malvia Cancer Centre. Private OPD Room No 41 Ground Floor BHU Campus, Sunderpur, Sundar Bagiya Nariya Varanasi Uttar Pradesh India Pin 221005 
Type of Sponsor  Research institution 
 
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 
SOMNATH DEY  MPMMCC and HBCH, Varanasi  Department of Pain and Palliative Medicine Mahamana Pandit Madan Mohan Malvia Cancer Centre Sunderpur Campus Private OPD Room No 41 Ground Floor Sundar Bagiya Nariya Varanasi
Varanasi
UTTAR PRADESH 
7595802711

drdeysomnath@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahamana Pandit Modan Mohan Malviya Cancer Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No human participant. only lab data based study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Demographic Data: Information on DMG, age, gender, diagnosis and any particular medical history.
2. Vitamin D3 Status: Measured through blood tests for 25-hydroxyvitamin D [25(OH)D] levels.
3. Sample size – 7000 (583 approx patients per month for 12 months duration) (Approximately 3500 patients seen per month in Palliative medicine department. Out of that nearly 500-600 patients per month was referred with serum Vitamin D level assessment. 
 
ExclusionCriteria 
Details  Patient without diagnosis of cancer 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of Vitamin D levels associated with cancer patients visited in the palliative medicine OPD  It will be measured only once at the first visit when patients come to OPD. 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="6000"
Sample Size from India="6000" 
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)   29/12/2025 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Prevalence of Vitamin D deficiency in cancer patients attending in Palliative Medicine Department: Review from a tertiary cancer centre

 

 

Introduction

 

Vitamin D, often referred to as the "sunshine vitamin," plays a vital role in maintaining human health[1]. It plays a crucial role in various physiological processes, including bone health, immune function, and overall well-being. However, despite its recognized importance, vitamin D deficiency remains a prevalent and underdiagnosed health concern, affecting individuals across various demographic groups[2,3].

The practice of palliative care focuses on enhancing the quality of life for individuals facing serious illnesses, offering comprehensive support that encompasses physical, psychological, and emotional well-being[4]. Addressing the nutritional needs of palliative care patients is an integral part of this holistic approach. While much attention has been given to pain management, symptom control, and emotional support in palliative care, the nutritional aspects of care, including the assessment and management of vitamin D deficiency, have not received the same level of scrutiny.

 

Palliative care patients are at an increased risk of vitamin D deficiency due to reduced sun exposure, limited mobility, and altered nutritional intake[5–7]. Vitamin D deficiency in palliative care patients may exacerbate their already compromised quality of life. Previous studies have shown that low levels of vitamin D in the blood may be associated with pain, sensitivity to infection, fatigue, depression, and lower self-rated quality of life[8,9]. Identifying and addressing vitamin D deficiency can complement pain management strategies, potentially improving symptom control and quality of life.

 

The relationship between vitamin D deficiency and skeletal health is well- established[10]. In palliative care, where patients may already experience frailty and limited mobility, the risk of fractures and bone-related complications is heightened. Supplementation and strategies to maintain optimal vitamin D levels could be instrumental in reducing skeletal complications in this patient population.

 

Vitamin D deficiency can compromise the immune system[11,12] potentially increasing the risk of infections in palliative care patients who are already immunocompromised. Preventing infections and their associated complications is paramount in palliative care, as infections can lead to hospitalizations and worsen patients’ quality of life[9].

 

Multiple studies have been published showing vitamin D deficiency among general population and few studies have focused on Vitamin D deficiency among palliative care patients. To our knowledge, no study from South east Asian countries on vitamin D deficiency in palliative cancer patients have been published .This comprehensive study aims to investigate the prevalence of vitamin D deficiency in cancer patients attending


in Palliative Medicine as outpatient. By shedding light on this relatively understudied aspect of palliative care, we seek to provide healthcare practitioners, researchers, and policymakers with a better understanding of the role of vitamin D in the well-being of these patients. Additionally, this study will explore whether vitamin D supplementation, dietary adjustments, or increased exposure to sunlight may offer practical solutions to mitigate the effects of deficiency, ultimately improving the palliative care experience for patients facing serious illness.

 

 

Methodology

 

The study employs a cross-sectional retrospective observational design to examine the prevalence of vitamin D deficiency and its implications in palliative care patients. This design allows for the collection of data at a single point in time and offers insights into the current status of vitamin D deficiency in this specific patient population.

 

The study will be conducted at MPMMCC & HBCH VARANASI, PAIN & PALLIATIVE MEDICINE DEPARTMENT which takes care of physical, social, psychological and spiritual needs of cancer patients irrespective of their disease trajectory. So, we have accessibility to a diverse group of patients from early palliative care to end of life care.

 

Duration of study: Cancer patients attended in Pain and Palliative Medicine OPD/IPD during the period from June 2023 – November 2023, retrospectively the data will be collected on a excel sheet from Biochemistry laboratory.

 

Data Collection

 

1.  Demographic Data: Information on DMG, age, gender, diagnosis and any particular medical history.

2.     Vitamin D3 Status: Measured through blood tests for 25-hydroxyvitamin D [25(OH)D] levels.

3.  Sample size 3000 (500 patients per month for 6 months duration)

5. Data Analysis - The data will be collected on excel sheet from Biochemistry laboratory. Then collected data will be analysed using appropriate statistical software. Descriptive statistics will be used to summarize demographic characteristics, vitamin D levels. Inferential statistics, such as t-tests and regression analysis, will be applied to assess the relationships between vitamin D deficiency, opioid consumption and palliative care outcomes.


Discussion

 

To the extent of our knowledge, this is first of its kind study in Northern and Central Northern part of India where we are going to analyse the large number of cancer patient’s data on Vitamin D3 level attending in Pain and Palliative Medicine Department of a tertiary care cancer hospital.

 

The clinical implications of this study are noteworthy. Prior routine assessment of vitamin D levels should be incorporated into the standard palliative care assessment and when deficiencies are identified, healthcare providers can initiate interventions with vitamin D supplementation and dietary modifications to improve patients’ nutritional status.

A clinical study revealed that more than 80% of palliative cancer patients have serum levels of 25-OHD below 50 nmol/L[5]. It could also be explained by the fact that many patients with cancer spend a large portion of their time indoors not taking varying UVB exposure into account is a possible limitation of Vitamin D deficiency.

There are a number of studies which examine and compare the effects of Vitamin D levels in palliative care patients and the importance of routine vitamin D assessments in palliative care to identify and address deficiencies promptly [8,9,14].

 

Few studies suggest a role of vitamin D in pain intensity and in management of pain in varying clinical settings[5,14,15]. A recent review of published RCTs concluded that a significantly greater mean decrease in pain score could be observed with vitamin D supplementation compared to placebo treatment in patients with chronic pain[16]. There is also increasing evidence that vitamin D supplementation may reduce depressive symptoms and improve quality of life[17].

Frankling et al in a randomized controlled study concluded that patients who received vitamin D supplements had a reduced need for pain relief and lower levels of fatigue in palliative cancer treatment.[9]

 

Since pharmacological treatment options for fatigue in palliative care are limited, and the evidence bases for these treatments are weak [8,10], the reported positive effect of vitamin D is highly interesting and deserves further study

 

Few studies have reported both the endpoints ‘opioid-dose’ and ‘antibiotic consumption’ to be valuable, reliable and clinically meaningful measurements for assessing therapeutic effects of vitamin D in palliative care patients[5,8,18,19].

In palliative cancer patients, infections as well as antibiotic treatment are frequent[20]. In a recent retrospective study 49 % of patients were treated with antibiotics during the last two weeks of life which not only increases the hospital stay of the patients but also reduces the quality of life and adds to financial burden [19].In a case controlled study of 39 patients the authors found improvement in pain management and QoL within 4 weeks of initiation of vitamin D in palliative cancer patients and decreased infection rate in 3 months. The authors also concluded that vitamin D supplementation in patients


with low serum levels of vitamin D can reduce the number of days the patients were treated with antibiotics thereby reducing the risk of multi-resistant bacteria[8].

 

Genetic polymorphism in the vitamin D receptor and in genes metabolising vitamin D is widely studied in relationship to cancer risk, musculoskeletal pain and infectious and autoimmune diseases[21]. Pain, infections and fatigue impair QoL in palliative cancer patients. Vitamin D is a non-toxic substance that can be combined with most medications prescribed to the palliative care patients. Therefore, Vitamin D supplementation is required to improve the well-being and decrease infections and pain.

 

That is why research is needed to explore the most effective vitamin D supplementation strategies and dosages in palliative care, considering potential interactions with medications and individual patient characteristics. However, this study has several limitations, including the use of convenience sampling, which may introduce selection bias. Additionally, the cross-sectional design limits our ability to establish causation and assess long-term changes in vitamin D status. Future research could employ longitudinal designs to address these limitations.

 

 

Conclusion

 

In conclusion, our comprehensive study will demonstrate a significant prevalence of vitamin D deficiency in palliative care patients, with potential implications for their quality of life, skeletal health, and immune function. The findings will underscore the importance of routinely assessing vitamin D levels in palliative care and implementing interventions to address deficiencies. These measures have the potential to enhance the palliative care experience and improve the well-being of patients facing advanced illnesses. In our subsequent studies, we are planning to analyse the correlation between different opioids sensitivity varies with Vitamin D3 level and if any improvement after Vitamin D3 correction therapy.

 

 

 

Ethical Considerations

The study protocol will be submitted for ethical committee clearance before the start of the study.

 

Conflict of interest

None



 
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