| 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
|
|
|
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
|
|
|
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. |