| CTRI Number |
CTRI/2026/04/108057 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Iron, Vitamin B, Zinc and Vitamin D Low dose Supplementation on Stress, Anxiety and Depression among 11-19 years in Kolar District: A Cluster Randomised Controlled Trial |
|
Scientific Title of Study
|
Nutritional supplementation for stress, anxiety and depression among adolescent boys and girls: A cluster randomized controlled trial |
| 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 Pradeep TS |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
No 34, 3rd floor, College Block
Department of Community Medicine,
Tamaka, Kolar
Karnataka-563103
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academic Higher Education and Research,
Tamaka, Kolar, Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
9538075331 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep TS |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
No 34, 3rd floor, College Block
Department of Community Medicine,
Tamaka, Kolar
Karnataka-563103
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academic Higher Education and Research,
Tamaka, Kolar, Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
9538075331 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep TS |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
No 34, 3rd floor, College Block
Department of Community Medicine,
Tamaka, Kolar
Karnataka-563103
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academic Higher Education and Research,
Tamaka, Kolar, Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
9538075331 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell
Sri Devaraj Urs Academic of Higher Education and Research,
Tamaka,Kolar,karnataka,India - 563103 |
|
|
Primary Sponsor
|
| Name |
Research and Development Cell |
| Address |
Sri Devaraj Urs Academic of Higher Education and Research, Tamaka,Kolar,karnataka,India - 563103 |
| Type of Sponsor |
Private 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 Pradeep TS |
Sri Devaraj Urs Medical College |
Department of Community Medicine
Sri DEvaraj Urs Academic of Higher Education and Research
Tamaka,
Kolar
KARNATAKA |
9538075331
dr.pradeep.ts@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Academy of Higher Education and Research and Development Cell/Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ARM 1 – IRON SUPPLEMENTATION |
Oral iron supplementation will be provided in sachet form. Each participant will receive elemental iron as per recommended dietary allowance for adolescents. Supplement will be administered daily under supervision for nine weeks. Adherence will be monitored by weekly follow up and supplement intake will be directly observed. |
| Intervention |
ARM 2 – ZINC SUPPLEMENTATION |
Oral zinc supplementation will be provided in sachet form containing nine to eleven milligram elemental zinc per day. Supplement will be administered daily under supervision for eight to nine weeks. Adherence will be ensured through supervised intake and weekly follow up visits. |
| Intervention |
ARM 3 – VITAMIN B12 SUPPLEMENTATION |
Oral vitamin B12 supplementation will be administered in sachet form as per recommended dietary allowance for adolescents. Supplement will be given daily under supervision for nine weeks. Compliance will be monitored through supervised administration and weekly follow up. |
| Intervention |
ARM 4 – VITAMIN D SUPPLEMENTATION |
Vitamin D3 supplementation will be administered as sixty thousand international units once monthly for two months. This is equivalent to approximately two thousand international units per day. Supplement will be given under supervision and participants will be monitored weekly. |
| Comparator Agent |
Health Education Control Group |
Participants in the control group will receive standard health education sessions on nutrition and mental health. No micronutrient supplementation will be provided. All participants will undergo baseline and post intervention assessment similar to intervention groups. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Adolescent boys and girls studying in selected government high schools in Kolar. Participants aged 10 to 10 years with mild to moderate stress, anxiety, or depression scores based on screening scales. Willing to provide assent and whose parents or guardians provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Participants with severe psychiatric illness requiring immediate clinical intervention. Those currently receiving psychiatric medication. Adolescents with chronic systemic illness. Known allergy or hypersensitivity to study supplements. Severe anemia requiring therapeutic management. Those unwilling to participate or without parental consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Depression score measured using Beck Depression Inventory II from baseline to nine weeks post intervention. |
Change in Depression score measured using Beck Depression Inventory II from baseline to nine weeks post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Anxiety score measured using Hamilton Anxiety Rating Scale from baseline to nine weeks. |
Baseline and nine weeks post intervention. |
| Change in Perceived Stress score measured using Perceived Stress Scale ten from baseline to nine weeks. |
Baseline and nine weeks post intervention. |
| Change in serum Vitamin D levels from baseline to nine weeks. |
Baseline and nine weeks post intervention |
| Change in serum Vitamin B12 levels from baseline to nine weeks. |
Baseline and nine weeks post intervention. |
| Change in serum Zinc levels from baseline to nine weeks. |
Baseline and nine weeks post intervention. |
| Change in serum Iron levels from baseline to nine weeks. |
Baseline and nine weeks post intervention. |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
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)
|
21/05/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Adolescent mental health problems such as stress anxiety and depression are increasing globally and are often associated with nutritional deficiencies. Micronutrients such as iron vitamin B12 zinc and vitamin D play an important role in brain function neurotransmitter synthesis and emotional regulation. Deficiencies of these nutrients are common among adolescents in India and may contribute to poor mental health outcomes.
This study aims to evaluate the effectiveness of iron vitamin B12 zinc and vitamin D supplementation on stress anxiety and depression scores among adolescent boys and girls studying in government high schools in Kolar Taluka. This is a cluster randomized controlled trial in which selected high schools will be randomized into different intervention arms including iron supplementation vitamin B12 supplementation zinc supplementation vitamin D supplementation and a health education control group.
Baseline assessment of depression anxiety and stress will be done using validated scales. Serum levels of micronutrients will also be assessed. Supplements will be administered under supervision for nine weeks. Post intervention assessment will be conducted to evaluate changes in psychological scores and micronutrient levels.
The findings of this study may help to determine whether nutritional supplementation can be used as a preventive or supportive strategy to improve adolescent mental health in community settings. |