| 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
|
|
|
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
|
|
|
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. |