A Study to Determine the Patient and Disease Profile and Treatment provided to Patients who do not have optimum levels of Vitamin D

Not yet recruiting

• Conditions: Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,

• Registration Number: CTRI/2020/03/024109
• Lead Sponsor: Abbott India Ltd

Brief Summary

This is a study to determine patient and disease profile in adult patients with Vitamin D deficiency.The study will enroll approximately 200 patients with vitamin D deficiency/insufficiency in approximately 10 sites. Clinical signs and symptoms, physical examinations at baseline and weeks 4 and 8 will be summarized using descriptive statistics.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-03-19
• Study Start: 2020-03-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male or female patients aged ≥ 18 years 2.
• Patients newly diagnosed with vitamin D deficiency or insufficiency of known or unknown origin.
• Patients who are willing to provide written patient authorization 4.
• Patients with stable anti-hypertension treatment for last 2 months.
• In case of Hypertension sub-group only.
• Patients with stable anti-diabetes treatment for last 2 months.
• In case of Diabetes subgroup only.

Exclusion Criteria

• Patients already on treatment for vitamin D deficiency/insufficiency 2.
• Female patients who are pregnant 3.
• Patients with a serum level of 25(OH)D > 30 ng/mL 4.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To understand the patient profile in terms of demographic and anthropometric measurements, exposure to sunlight, lifestyle pattern, and socioeconomic status	Week 4 and 8
2.To determine the clinical characteristics in terms of clinical signs and symptoms at baseline and weeks 4 and 8	Week 4 and 8

Secondary Outcome Measures

Name	Time	Method
1.Type and number of comorbidities at baseline.	2.Proportion of patients who are prescribed with vitamin D supplements, including its formulation (as tablets/capsules, injections, or granules in sachets), dose, route, frequency, and duration at weeks 4 and 8

Trial Locations

Locations (5)

Ashraya Clinic; 🇮🇳 Bangalore, KARNATAKA, India

Bhardwaj Ortho Centre; 🇮🇳 East, DELHI, India

Dr Rakesh Sharma’s clinic; 🇮🇳 West, DELHI, India

Shilpa Medical Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Swarnarani Clinic; 🇮🇳 Bangalore, KARNATAKA, India

Ashraya Clinic

🇮🇳Bangalore, KARNATAKA, India

Dr Akhila Rao

Principal investigator

9449800493

akrao3@gmail.com