Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients

NCT04917458 | Unknown Phase 2

• 1 other identifier: 20-05-0484
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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

Keywords

Diabetes Mellitus, Type 2; Depression; Cholecalciferol

Outcome Measures

Primary Outcomes (1)

• Evaluating the effects of cholecalciferol for depression symptoms with BDI II score

  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.

  90 days

Secondary Outcomes (3)

• Evaluating the effects of cholecalciferol against neuroplasticity (NT-3)

  30 days

• Evaluating the effects of cholecalciferol against serotonin

  30 days

• Evaluating the effects of cholecalciferol against C-Peptide

  30 days

Study Arms (2)

Cholecalciferol

EXPERIMENTAL

-Vitamin D 25 (OH) 4000 IU capsules, tablet @ 1000 IU One capsule for once a day for 30 days of study period.

Drug: Cholecalciferol 4000 IU Oral Capsule, Liquid Filled

Control Group

PLACEBO COMPARATOR

Placebo will be administrated orally, One capsule once a day for 30 days of study period

Drug: Placebo

Interventions

Cholecalciferol 4000 IU Oral Capsule, Liquid Filled DRUG

-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.

Also known as: Vitamin D3

Cholecalciferol

Placebo DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo National General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression

Interventions

Cholecalciferol; Capsules

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Rudi Putranto

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rudi Putranto

CONTACT

+622131926052; putranto.rudi09@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients included into the study will be randomized into two groups and receive placebo (as control group) or 4000 IU Vitamin D (as therapy group) once a day for 90 days. Randomization and blinding code preparation will be performed by using block permuted randomization technique with a block size combination of 4 and 6. The randomized intervention code was hidden in a closed envelope to avoid knowing the sequence of the therapy given. All packaging and labeling of the study products will be prepared by Pharmacy Departement Ciptomangunkusumo General Hospital. The study products will be prepared in such packages which will be recognized as products for clinical trial only. In order to keep the blinding procedures, the study drugs will all be provided by Pharmacy Department in a double-blind double-dummy preparation. Placebo tablet will also be prepared by Pharmacy Department and made identical in appearance with the active tablets.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This is a prospective, randomized, double blind, and controlled clinical study to investigate the effects of cholecalciferol on depressive symptoms in type 2 diabetes mellitus patients. Patients included into the study will be randomized into two groups and receive placebo (as control group) or cholecalciferol administered orally for 3 months.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: June 8, 2021
• Study Start: January 18, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)