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Effects of Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients: Study of Neurotrophin-3, Serotonin, and C-Peptide
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.
Details
| Lead sponsor | Indonesia University |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 90 |
| Start date | 2021-01-18 |
| Completion | 2021-10 |
Conditions
- Diabetes Mellitus, Type 2
- Depressive Symptoms
Interventions
- Cholecalciferol 4000 IU Oral Capsule, Liquid Filled
- Placebo
Primary outcomes
- Evaluating the effects of cholecalciferol for depression symptoms with BDI II score — 90 days
Improvement rate on days 90 (end of study) as defined by a proportion of subjects with category of BDI II score below 13. The BDI II scale was a subjective measurement of depressive symptoms. Interpretation of BDI II were 0-13 for minimal depression, 14-19 for mild depression, 20-28 for moderate depression, and 29-63 for major depression. Cholecalciferol with doses of 4000 IU a day expected to demote BDI II scale or depressive symptoms in participants.
Countries
Indonesia