Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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 DM patients. Depression in diabetes patients is also associated with decreasing quality of life. Poor self-care behavior and adherence, poor glycemic control, and increased risk of mortality about 36-38% from cardiovascular complications are other known debilitating results.

Vitamin D receptors are present in many organ systems, namely the pancreas, intestine, musculoskeletal, and nervous systems. Vitamin D has pleiotropic effects, which were seen from its mechanism as an anti-inflammatory, anti-apoptotic, and immunomodulatory agent. Based on the mechanism of Vitamin D action in the nervous system, which also plays a role in depression pathogenesis, vitamin D is hypothesized to have a beneficial effect on depression, both for depression prevention and treatment. Few studies denote that Vitamin D can improve depression in type 2 DM patients. Vitamin D may become an important adjuvant therapy to ameliorate depression in type 2 DM patients. These clinical trials concerning vitamin D in type 2 DM are relevant, reminding that type 2 DM resulted in higher morbidity, mortality, and numerous high-risk complications in the population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University
• Treatments: Cholecalciferol; Vitamin D

Criteria

Inclusion Criteria:

• 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 Criteria:

• - 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