Status:
UNKNOWN
Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients
Lead Sponsor:
Indonesia University
Conditions:
Diabetes Mellitus, Type 2
Depressive Symptoms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
One in eleven adults falls ill with Diabetes Mellitus (DM) and 90% of them suffered from type 2 DM. Depression in type 2 DM patients had a big impact, acting as a major barrier to self-care in type 2 ...
Detailed Description
According to World Health Organization report's, depression was estimated causing distress in most people on 2030. 1 In Indonesia, the prevalence of depression in 2017 was 3,7%.2 Depression often foun...
Eligibility Criteria
Inclusion
- Male or female subjects with aged 18 and over
- Living in around Jakarta
- Type 2 diabetes mellitus patients with depression symptom
- Patients with Body mass index 20-30 m/kg2
- Patients are able and willing to maintain diet, physical activity, and lifestyle for 3 months
- Patients are able and willing to control for follow up
Exclusion
- \- Presence of severe hepatic dysfunction, defined as cirrhosis hepatic
- Presence of severe renal dysfunction, defined as chronic kidney disease stage 5 or e-GFR ≤15 or history of hemodialysis
- Patients with acute coronary syndrome
- Presence of acute systemic inflammatory response syndrome (SIRS). The term SIRS describes a clinical state arising from a non-specific cause, infective, or otherwise
- Recent obtained vitamin D therapy within the last 3 months
- Current or regular use of corticosteroids within immunosuppressant dosage
- Presence of major depression
- Presence of psychosis
- Current or regular use of anti-depressant
- Current or regular use of phenytoin or phenobarbital
- For females: current pregnancy and lactation period
- Patients who refuse the studies
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04917458
Start Date
January 18 2021
End Date
October 1 2021
Last Update
June 8 2021
Active Locations (1)
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1
Cipto Mangunkusumo National General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430