| CTRI Number |
CTRI/2025/09/094490 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Sunlight exposure] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study on how air pollution affects vitamin D producing sunlight and vitamin D levels in school children |
|
Scientific Title of Study
|
Pilot study on the impact evaluation of atmospheric pollutants on UVB rays of wavelength 290-315 nm reaching earth’s surface and its effects on vitamin D synthesis among school students. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Rajni Sharma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 830, Mother Child block, Division of Pediatric Endocrinology, Department of Pediatrics, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811334144 |
| Fax |
|
| Email |
drrajnisharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajni Sharma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 830, Mother Child block, Division of Pediatric Endocrinology, Department of Pediatrics, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811334144 |
| Fax |
|
| Email |
drrajnisharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ridhima Rathod |
| Designation |
Student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9704545349 |
| Fax |
|
| Email |
ridhimarathod44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Society for Endocrine Health Care of Elderly, Adolescents
and Children (SEHEAC)
92E/I, Ground Floor, Munirka Market,
New Delhi, Delhi 110067, India |
|
|
Primary Sponsor
|
| Name |
Society for Endocrine Health Care of Elderly, Adolescents and Children (SEHEAC) |
| Address |
GROUND FLOOR, 92E/I, MARKET, Munirka, New Delhi, Delhi 110067 |
| Type of Sponsor |
Other [Non-governmental organization] |
|
|
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 Rajni Sharma |
All India Institute of Medical Sciences, New Delhi |
Room number 830, Mother Child block, Division of Pediatric Endocrinology, Department of Pediatrics, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi
New Delhi
DELHI |
9811334144
drrajnisharma@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vitamin D sufficiency |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Day-to day activities |
Children will continue with their day-to day activities |
| Intervention |
Sunlight exposure |
Daily 30 minutes sunlight exposure from 11:00 am to 11:30 am for 1 year. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases: Class 9 students of both genders studying in a government school (12-16 year old children)
2. Controls: Class 8 students of both genders studying in a government school (12-16 year old children)
|
|
| ExclusionCriteria |
| Details |
1. Subjects with any chronic illness
2. Those on medications that interfere with the evaluation of bone mineral metabolic parameters like anticonvulsant, antitubercular drugs, barbiturates and steroids.
3. Use of sunscreens
4. Using vitamin D or calcium supplements in last 3 months
5. Skin disease
6. Refusal to consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum 25 (OH) Vitamin D levels, measured by chemiluminescence.
|
4 monthly: in the Summer season (April- May), Rainy season (August-September), Winter Season (January-February) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between AQI index and Serum 25 (OH) Vitamin D levels |
4 monthly: in the Summer season (April- May), Rainy season (August-September), Winter Season (January-February) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drrajnisharma@yahoo.com].
- For how long will this data be available start date provided 01-06-2026 and end date provided 01-06-2065?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This pilot study aims to evaluate the impact of atmospheric pollutants on the intensity of ultraviolet B (UVB) rays (wavelength 290–315 nm) reaching the Earth’s surface and to examine their consequent effect on vitamin D synthesis among school-going children. The study is a collaborative effort between the Department of Pediatric Endocrinology, AIIMS New Delhi, and the Society for Endocrine Health Care of Elderly, Adolescents and Children (SEHEAC). By correlating environmental data on air quality and UVB irradiance with serum vitamin D levels in participants, the study seeks to explore how pollution-mediated attenuation of UVB rays may contribute to hypovitaminosis D. The findings are expected to provide preliminary evidence for broader epidemiological studies and inform public health strategies targeting vitamin D deficiency in pediatric populations. |