FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/05/019264 [Registered on: 21/05/2019] Trial Registered Prospectively
Last Modified On: 07/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To check the Vitamin D status in healthy population 
Scientific Title of Study   Assessment of serum vitamin D levels in apparently healthy individuals.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravi Gupta 
Designation  Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of Orthopaedics Government Medical College and Hospital, Sector 32 Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121592  
Fax    
Email  ravikgupta2000@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravi Gupta 
Designation  Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of Orthopaedics Government Medical College and Hospital, Sector 32 Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121592  
Fax    
Email  ravikgupta2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaibhav  
Designation  PG Resident 
Affiliation  Government Medical College and Hospital 
Address  Department of Orthopaedics Government Medical College and Hospital, Sector 32 Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  9872741748  
Fax    
Email  drvaibhavbohat@gmail.com  
 
Source of Monetary or Material Support  
Govt. Medical College & Hospital, sector 32B, Chandigarh 
 
Primary Sponsor  
Name  Govt Medical College and Hospital 
Address  Govt. Medical College & Hospital Sector 32 Chandigarh 
Type of Sponsor  Government medical college 
 
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 Vaibhav   Government Medical College and Hospital, Chandigarh  Orthopaedic Surgery OPD Room No 3208 Govt Medical college and Hospital sector 32 chandigarh
Chandigarh
CHANDIGARH 
9872741748

drvaibhavbohat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (GMCH, Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Both Sexes
-7 years old and above
-Apparently healthy individuals visiting our department for ailment unrelated to vitamin D
deficiency
-No co-morbidities (American Society of Anesthesiologists - ASA grade 1 and 2)
-Not taking vitamin D supplementation for the last 6 months.  
 
ExclusionCriteria 
Details  -Presence of liver disease / renal disease / gastrointestinal disease / metabolic bone disease
-Suffering from a skin disease affecting melanin pigmentation
-Taking steroids / ketoconazole / antiretroviral drugs
-Abnormal DEXA scan  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Vitamin D status in apparently healthy individuals and to correlate it with available reference values.   1 year and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Association of vitamin D levels with other biochemical markers and DEXA scan.   1 year and 6 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   01/06/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Vitamin D is a fat soluble vitamin, steroidal in structure and hormonal in function.[1] Vitamin D was first discovered in early 1900s when children suffering from rickets got cured after supplementation with fish cod liver oil.[2] It is the only vitamin that is produced in the skin with help of UV rays from sunlight.[3,4,5] The principle function of vitamin D is to regulate plasma calcium concentration by acting mainly on three target organs - on intestine (increases calcium absorption)[6], on the kidney (decreases urinary excretion of calcium)[7- 9] and on the bone (increases bone resorption resulting in bone mineralization and remodeling).[10]
Besides increasing the calcium and phosphorus levels in the extracellular fluid to mineralize new bone, vitamin D also has extra skeletal effects in the body. It modulates the transcription of cell cycle proteins that decreases cell proliferation and increases cell differentiation of a number of specialized cells of the body (e.g. enterocytes, keratinocytes, etc.).[11-13] Vitamin D toxicity can also develop due to more than required supplementation which causes increased calcium levels. Hypercalcaemia causes fatigue, loss of appetite, weight loss, excessive thirst, excessive urination, dehydration, constipation, irritability, nervousness, ringing in the ear (tinnitus, muscle weakness, nausea, vomiting, dizziness, confusion, disorientation, high blood pressure, heart arrhythmias, etc. The consequences of vitamin D deficiency are low calcium and phosphate, increased parathormone(PTH) producing secondary hyperparathyroidism, a further reduction in phosphate levels and increased plasma levels of bone-derived alkaline phosphatase. Clinically, low vitamin D produces poor bone mineralization - rickets in children, osteomalacia in adults. Extra skeletal manifestations of vitamin D deficiency include depression, increased risk of fracture, limb girdle muscle weakness, muscle twitching (fasciculation), pre-eclamsia,etc.[14] Despite ample sunshine in India, 70-100% Indians in different age groups are reported to be vitamin D insufficient or deficient.[15] But this deficiency is according to western reference scale. While osteomalacia and rickets have been studied extensively, there is little information on vitamin D deficiency without obvious bone disease. As per western statistics, vitamin D deficiency is defined as a serum 25(OH)D level <50 nmol/L (<20 ng/mL), whereas a serum 25(OH)D level of >75 nmol/L (>30 ng/mL) is considered to be normal, and a level 2 of 50-75 nmol/L (20-30 ng/mL) defines vitamin D insufficiency. According to this, majority of Indian population are insufficient or deficient yet are asymptomatic. There was a retrospective analysis of the vitamin D levels measured at a major medical center in Hyderabad, India. Vitamin D levels measured as a part of a routine health check were reviewed. A further analysis done on the basis of gender and geographic location of the population in sample of 65 Indian females showed serum 25(OH)D level to be 12.12 ng/mL (range 3-47.5) while in 30 Indian males the mean level was 11.86 ng/mL.[16] In 2000, serum 25(OH)D measured using sensitive and specific assay in apparently healthy subjects in Delhi and showed that significant hypovitaminosis D was present up to 90 per cent population tested.[17] A study from eastern India in Kolkata, West Bengal conducted by Rudrajit Paul et al showed more than half of the study population had Vitamin D deficiency with 53% females and 33% males. In west India in study done in Maharashtra, 95% of total population had hypovitaminosis D.[18] The northern and southern states in India too had similar findings of Vitamin D deficiency in majority of normal population.[19]Subclinical vitamin D deficiency has been reported to be highly prevalent in both urban and rural settings, and across all socioeconomic and geographic strata. According to the western reference scale, 70-100 % Indian population who are found to be vitamin D deficient should have poor bone quality. We hypothesize that the incidence of hypovitaminosis in Indian population is inflated because the western reference scale do not correspond to normal Indian values. Thus studies are required in India to estimate the serum vitamin D levels in normal and healthy population.  
 
Close