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

A Study to Determine the Patient and Disease Profile and Treatment Paradigm in Adult Patients Diagnosed with Vitamin D Deficiency/Insufficiency - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/03/024109
Enrollment
200
Registered
2020-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

None listed

Sponsors

Abbott India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged >= 18 years 2. Patients newly diagnosed with vitamin D deficiency or insufficiency of known or unknown origin. 3. 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. 5. Patients with stable anti-diabetes treatment for last 2 months. In case of Diabetes subgroup only.

Exclusion criteria

Exclusion criteria: 1. 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. Patients who are not willing to provide written patient authorization

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 3. Change in 25(OH)D levels from baseline to weeks 4 and 8 4. Number and proportion of patients with adverse events (AEs)/serious AEsTimepoint: Week 4 and 8

Countries

India

Contacts

Public ContactDr Shivani Acharya

Abbott India Ltd

srirupa.das@abbott.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026