To identify the benefits of supplementation of vitamin D under supervision as compared to self administration among vitamin D deficient staff working in anesthesia department

Phase 2/3

Not yet recruiting

• Conditions: Anaesthesia staff technicians with serum vitamin D level less than 30ng/ dl

• Registration Number: CTRI/2020/01/023087
• Lead Sponsor: fluid research fund

Brief Summary

This is an interventional study among the healthcare workers in the department of anaesthesia ,CMCH, Vellore, who are found to have deficiency in serum vitamin D levels. The staff workers who are found to have vitamin D levels below the recommended normal values are recruited for the study. A semi-structured questionnaire will be administered to assess the symptoms of vitamin D deficiency, type of work they are involved in, duration of sun exposure, compliance to vitamin D supplementations. The study  population is then randomized to two groups observed and unobserved. Participants in the observed group are supplemented under direct observation while the subjects in the unobserved group are asked to take on their own as per the prescribed schedule and to bring back the empty sachets at the end of study. The difference in increase of serum vitamin D levels in both groups are tested, along with assess the improvement in symptoms, compliance  and quality of life

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-02
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

healthy volunteers with 25(OH)D levels < 30 ng/ml.

Exclusion Criteria

age less than 18 years subjects with chronic illness and other endocrine disorders subjects who are on vitamin D supplementation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparing the difference in the improvement of serum vitamin D level at the end of eight months of supplementation of 25(OH)d to both groups	comparing the difference in the improvement of serum vitamin D level at the end of eight months of supplementation of 25(OH)d to both groups

Secondary Outcome Measures

Name	Time	Method
improvement in symptoms of vitamin D	improvement in health related quality of life

Trial Locations

Locations (1)

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Christian Medical College

🇮🇳Vellore, TAMIL NADU, India

Dr Reshma Mariam Biju

Principal investigator

8270704709

reshandjeff@gmail.com