CTRI/2024/01/061970CompletedUnknown
Assessment of the impact of Vitamin D3 supplementation on sleep quality in adults with vitamin D deficiency
MS Ramaiah Medical College and Hospital1 site in 1 country98 target enrollmentStarted: February 1, 2024Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Improvement in sleep quality
Study Overview
Brief Summary
- This study is designed as a randomised controlled trial where all the adults detected with vitamin D deficiency when screened for the indications based on standard guidelines or incidentally detected will be included and divided into 2 arms where one arm receives a weekly 60000 IU of oral Vitamin D3 for a total of 8 weeks and the other arm receives 6000 IU daily for a period of 8 weeks in addition to advice on adequate lifestyle modifications and dietary changes given for both the groups. Standard questionnaire will be used to record the baseline sleep quality indices (Pittsburg Sleep quality index). After 8 weeks, all the participants will be reassessed with the same standard questionnaire along with a repeat Vitamin D3 estimation. The sleep quality indices shall be compared between baseline and follow up to assess the efficient method of vitamin D3 supplementation in adults detected with Vitamin D deficiency.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Lab evidence of Vitamin D3 deficiency detected when screened as per guidelines for fibromyalgia or nonspecific musculoskeletal complaints and incidentally detected patients.
Exclusion Criteria
- •Those on sedatives, granulomatous disorders, volume overload status clinically, pregnant, anaemic, alcohol intake in last 3 months and those who deny to consent.
Outcomes
Primary Outcomes
Improvement in sleep quality
Time Frame: 0,8 week
Secondary Outcomes
- Correction of Vitamin D3 levels by effective method(0,8 week)
Investigators
Dr Lakshmi Priya
MS Ramaiah Medical College
Study Sites (1)
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