MedTrace Logo

Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients

NCT04917458 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-06-08

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Depressive Symptoms

Interventions

DRUG

Cholecalciferol 4000 IU Oral Capsule, Liquid Filled

-Vitamin D 25 (OH) or Cholecalciferol 4000 IU capsules, each capsules contain Vitamin D3 tablet @ 1000 IU Patients included into the study will be randomized into two groups and receive placebo (as control group) or cholecalciferol administered orally for 3 months.

DRUG

Placebo

Placebo will be given to control group. It would be administrated orally, one capsule once a day for 30 days of study period

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Rudi Putranto · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04917458 on ClinicalTrials.gov