1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Data are available indefinitely at (Link to be included ctri.nic.in).
   


6. For how long will this data be available start date provided 21-03-2021 and end date provided 21-12-2024?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Participants were randomly assigned to receive either Vitamin D or placebo. Participants will be provided with 12 weeks of study medication. Vitamin D will be given as DEKEL Nano Syrup once a day for 10-days. Apart from Vitamin D, both groups will receive treatment as usual including prescription of Escitalopram 10 mg or 20 mg, along with Clonazepam and a proton pump inhibitor (PPI). Both groups will also undergo psychiatric examination with diagnostic interview, cognitive behavior therapy, psycho-education and any other medication according to the treatment guidelines.

Randomization and Blinding

The participants will be randomized into two groups, intervention (Vitamin D with Standard Treatment) or control (Standard Treatment only) using blocks of four. The randomization procedure will be computer-generated and conducted in a labelling procedure concealed from the staff and investigators. Both the active drug and the placebo will be identical in size, smell, and taste.

Outcome Measures

·         Primary Outcome:

1. Sum of the Hamilton Rating Scale for Depression (17-items) (HAM-D17).

2. Score in Montgomery-Asberg Depression Rating Scale (MADRS).

Secondary Outcome:

1.Clinicians Global Impressions (CGI) Score

2. Incidence of adverse events.

Study Assessments:

Depression level and mental health will be assessed and diagnosed by an experienced Psychiatrist. The primary outcome will be assessed using HAM-D17 and MADRS whereas the secondary outcomes are assessed using CGI and the incidence of adverse events. All outcomes will be assessed at baseline and at the end of 3 months. Socio-demographic factors will be assessed at baseline. Known side effects of vitamin D supplementation, and severe adverse events, use of dietary supplements and a full medication list are recorded at baseline and follow-up.

Treatment adherence will be assessed by counting the number of bottles returned by the patients at 12 weeks.

25(OH) D, phosphate, calcium, PTH, HbA1c, TSH, T3 and T4 will be estimated, at baseline and then at the end of three months.