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CTRI Number  CTRI/2024/05/066905 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Vitamin D and Thyroid Function in patients with Anxiety and Depressive Disorder 
Scientific Title of Study   Serum 25-Hydroxyvitamin D levels and thyroid function tests in patients with Generalized Anxiety Disorder and Depressive Disorder 
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 Nikhita Loomba 
Designation  Post Graduate Resident 
Affiliation  University College of medical sciences and Guru Teg Bahadur Hospital 
Address  Department of Psychiatry, University college of medical sciences and Guru Teg Bahadur Hospital, Dilshad Garden

North East
DELHI
110095
India 
Phone  9811558354  
Fax    
Email  nikhitaloomba97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sanjay Agrawal 
Designation  Director Professor and Head of Department 
Affiliation  University College of medical sciences and Guru Teg Bahadur Hospital 
Address  Department of Psychiatry, University college of medical sciences and Guru Teg Bahadur Hospital, Dilshad Garden

North East
DELHI
110095
India 
Phone  9625900578  
Fax    
Email  hodpsychiatry@ucms.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nikhita Loomba 
Designation  Post Graduate Resident 
Affiliation  University College of medical sciences and Guru Teg Bahadur Hospital 
Address  Department of Psychiatry, University college of medical sciences and Guru Teg Bahadur Hospital, Dilshad Garden

North East
DELHI
110095
India 
Phone  9811558354  
Fax    
Email  nikhitaloomba97@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi- 110095 
 
Primary Sponsor  
Name  University college of medical sciences and Guru Teg Bahadur Hospital 
Address  University college of medical sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi- 110095 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr NIKHITA LOOMBA  University college of medical sciences and Guru Teg Bahadur Hospital  Department of Psychiatry, University college of medical sciences and Guru Teg Bahadur Hospital, Dilshad Garden, DELHI 110095
North East
DELHI 
9811558354

nikhitaloomba97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR), UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI, DELHI - 110095  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F411||Generalized anxiety disorder, (2) ICD-10 Condition: F33||Major depressive disorder, recurrent, (3) ICD-10 Condition: F32||Major depressive disorder, singleepisode,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with age between 18-60 years.
2. Patient must meet criteria for: Either
Primary diagnosis of Generalized Anxiety Disorder according to ICD-10 (The ICD-10 Classification of Mental and Behavioural Disorders) [Annexure 1]
OR
Primary diagnosis of Depressive episode- Mild, moderate or severe, or Recurrent Depressive Disorder according to ICD-10 (The ICD-10 Classification of Mental and Behavioural Disorders) [Annexure 2]
3. Patients should be able to read Hindi/English 
 
ExclusionCriteria 
Details  1. Lifetime ICD-10 diagnosis of schizophrenia, schizoaffective or bipolar disorders.
2. Patients previously diagnosed with and undergoing treatment for any significant or
chronic medical illness which alters vitamin D or thyroid hormone levels (renal disease,
thyroid dysfunction, hepatic disease)
3. Patients consuming vitamin D supplements in the last 6 months.
4. Pregnant or lactating women.
5. Patients with substance dependence of alcohol and illicit substances (except nicotine).
6. Patients not consenting for participation in the study or for giving blood sample. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum 25-hydroxyvitamin D levels in patients with Generalized Anxiety Disorder and
Depressive Disorder 
1 week 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate thyroid function tests in patients of Generalized Anxiety Disorder and Depressive Disorder.
2. To study the correlation of serum levels of 25-hydroxyvitamin D and thyroid function tests with severity of anxiety, if any.
3. To study the correlation of serum levels of 25-hydroxyvitamin D and thyroid function tests with severity of depression, if any 
1 week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/05/2024 
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="4"
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  

Anxiety disorders are the most common type of mental health problems and comprise of a range of disorders, the most common being Generalized Anxiety Disorder (GAD). Depression is a prevalent clinical condition identified by a lasting and significant low mood, featuring periods of diminished interest, slowed cognitive processes, and decreased voluntary engagement. Thyroid dysfunction has been acknowledged for its substantial impact on mental health, potentially giving rise to disruptions in both emotional well-being and cognitive function. Vitamin D possesses neuroprotective properties, influencing the synthesis of neuromediators, the production and release of neurotrophins, maintaining intracellular calcium homeostasis, and safeguarding nervous tissue from oxidative damage. Most studies examining the correlations between vitamin D and anxiety symptoms have involved a diverse population- healthy adults, patients hospitalized for severe depression and those with medical conditions, but there are few studies which have been done in patients with a primary anxiety disorder. While the role of thyroid hormones has been established in depression, contradicting results have been seen in anxiety disorders. There is a paucity of research on the association of vitamin D and thyroid hormones in patients with GAD. There are very few comparisons of these parameters in patients with GAD and depressive disorder done, and hardly any have been done in patients attending a tertiary care hospital in the Indian Subcontinent.


Patients fulfilling inclusion and exclusion criteria will be taken for the study. Minimum 60 patients will be enrolled for the same. They will be evaluated with the following

scales: Hamilton Rating Scale for Anxiety (HAM-A) will be used to clinically evaluate the patients and rate severity of anxiety symptoms, Hamilton Rating Scale for Depression (HAM-D) will be used to clinically evaluate the patients and rate severity of depressive symptoms, Depression, Anxiety and Stress Scale (DASS-21) will be used to screen patients for depression, anxiety and stress. Blood samples will be

collected for 25-hydroxyvitamin D levels and thyroid function test (fT3, fT4, TSH). Reports of CBC, LFT, KFT, fasting blood glucose and lipid profile (T.Ch, TG, HDL) will be noted from hospital records.


All data will be included with a study ID number and strict confidentiality will be maintained. Statistical analysis and comparison of data will be done using SPSS. Comparison of serum 25-hydroxyvitamin D levels and thyroid function tests will be done by parametric and non-parametric statistical tests, depending upon the nature of the data being normal or skewed Correlation of serum 25-hydroxyvitamin D levels and thyroid function tests with severity of anxiety and depression will be done by Pearson’s correlation coefficient.

 
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