Effect of Vitamin D supplementation in treatment of First episode Psychosis

Completed

• Conditions: Brief psychotic disorder, First Episode PSychosis, (2) ICD-10 Condition: F323||Major depressive disorder, singleepisode, severe with psychotic features, (3) ICD-10 Condition: F302||Manic episode, severe with psychotic symptoms, (4) ICD-10 Condition: F200||Paranoid schizophrenia,

• Registration Number: CTRI/2017/07/009136
• Lead Sponsor: Central Institute of Psychiatry

Brief Summary

The study is a randomised, double blind, placebo controlled, hospital based study. The subjects were recruited for the study by simple random sampling technique. Sample size consisted of 60 diagnosed drug naive( or drug free for a minimum of 4 weeks in case of oral psychotropic medication & 8 weeks for depot preparations) cases of First episode psychosis according to ICD-10 DCR. For those patients selected for vitamin D supplementation, 2000 IU/day of vitamin D along with regular psychotropic medications were given and the other group was treated with placebo and regular psychotropic medications. Blood sample examination for various parameters and clinical assessment were done at baseline and again at completion of 4 weeks. Serum vitamin D estimation was done by ELISA method.

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-06-20
• Study Start: 2015-12-30
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Either sex.
• Age: 18-45 years.
• Diagnosed cases of a.
• Schizophrenia (all subtypes) b.
• Mania with psychotic symptoms c.
• Severe Depression with psychotic symptoms d.
• Acute & Transient Psychotic Disorder ; fulfilling ICD-10 DCR (WHO, 1993) criteria.
• Status of patient should be drug naïve (or drug free for minimum 4 weeks for oral psychotropic medications & 8 weeks for depot preparations).
• Patients giving written informed consent.

Exclusion Criteria

• Presence of co-morbid psychiatric disorder.
• Individuals with history of substance use meeting dependence criteria, other than nicotine & caffiene.
• Co-morbid medical illness known to affect Vit.D level (Arthritis, Osteoporosis, Rickets, End Stage Renal Disease, Malabsorption Syndromes, Corticosteroid therapy).
• Patients already on Vitamin D supplementation.
• Patients receiving anticonvulsant medications as mood stabilizer.
• Patients with BMI more than 30kg/m².
• Menopausal females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brief Psychiatric rating scale, Positive and Negative Syndrome scale, Young Mania rating scale, Hamilton Rating scale for Depression	Baseline and at 4 weeks completion

Secondary Outcome Measures

Name	Time	Method
Serum Vitamin D level	Baseline and at 4 weeks completion

Trial Locations

Locations (1)

CENTRAL INSTITUTE OF PSYCHIATRY; 🇮🇳 Ranchi, JHARKHAND, India

CENTRAL INSTITUTE OF PSYCHIATRY

🇮🇳Ranchi, JHARKHAND, India

SATYAM KISHORE

Principal investigator

91-8521396648

sksrivastava1986@gmail.com