Skip to content

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

Nutritional supplementation for stress, anxiety and depression among adolescent boys and girls: A cluster randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108057
Enrollment
750
Registered
2026-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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 adolescent

Sponsors

Research and Development Cell
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Change in Depression score measured using Beck Depression Inventory II from baseline to nine weeks post intervention.Timepoint: Change in Depression score measured using Beck Depression Inventory II from baseline to nine weeks post intervention.

Secondary

MeasureTime frame
Change in Anxiety score measured using Hamilton Anxiety Rating Scale from baseline to nine weeks.Timepoint: Baseline and nine weeks post intervention.;Change in Perceived Stress score measured using Perceived Stress Scale ten from baseline to nine weeks.Timepoint: Baseline and nine weeks post intervention.;Change in serum Vitamin D levels from baseline to nine weeks.Timepoint: Baseline and nine weeks post intervention;Change in serum Vitamin B12 levels from baseline to nine weeks.Timepoint: Baseline and nine weeks post intervention.;Change in serum Zinc levels from baseline to nine weeks.Timepoint: Baseline and nine weeks post intervention.;Change in serum Iron levels from baseline to nine weeks.Timepoint: Baseline and nine weeks post intervention.

Countries

India

Contacts

Public ContactDr Pradeep TS

Sri Devaraj Urs Medical College

dr.pradeep.ts@gmail.com9538075331

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026