Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04917458
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
dr Rudi Putranto SpPD KPsi MPH, Indonesia University

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Depressive Symptoms Drug: Cholecalciferol 4000 IU Oral Capsule, Liquid Filled Drug: Placebo Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Effects of Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients: Study of Neurotrophin-3, Serotonin, and C-Peptide
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Cholecalciferol
-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
-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.
Other Name: Vitamin D3

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




Primary Outcome Measures :
  1. Evaluating the effects of cholecalciferol for depression symptoms with BDI II score [ Time Frame: 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.


Secondary Outcome Measures :
  1. Evaluating the effects of cholecalciferol against neuroplasticity (NT-3) [ Time Frame: 30 days ]
    NT-3 concentration (pg/ml) in the sample was determined by comparing the sample against the standard curve. Some studies have shown that neurotrophin-3 (NT-3 pg/ml) levels decreased in depression. Thus, cholecalciferol (for doses of 4000 IU a day) with expected could increase NT-3 pg/ml plasm levels. Furthermore, the enhancement of NT-3 pg/ml concentrates expected to had correlated with scale BDI II improvement.

  2. Evaluating the effects of cholecalciferol against serotonin [ Time Frame: 30 days ]
    Studies have shown that serotonin (ng/mL) in depressive patients had lower levels than patient without depressive syndrome. The serotonin levels were measured by the ELISA method. Cholecalciferol expected could increase levels of serotonin concentration (ng/mL) significantly 2-3 times after administrated.

  3. Evaluating the effects of cholecalciferol against C-Peptide [ Time Frame: 30 days ]
    C-peptide hormone is an indicator of insulin secretion. Specifically, a c-peptide level of less than 0.2 nmol/l is associated with a diagnosis of type 1 diabetes mellitus. C-peptide measured using ELISA at a minimal room temperature for 24 hours. Cholecalciferol expected could improve C-peptide levels concentration in type 2 Diabetes Mellitus.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04917458


Contacts
Layout table for location contacts
Contact: Rudi Putranto +622131926052 putranto.rudi09@gmail.com

Locations
Layout table for location information
Indonesia
Cipto Mangunkusumo National General Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Rudi Putranto    +622131926052    psikosomatik@yahoo.com   
Sponsors and Collaborators
Indonesia University
Investigators
Layout table for investigator information
Principal Investigator: Rudi Putranto Indonesia University
Layout table for additonal information
Responsible Party: dr Rudi Putranto SpPD KPsi MPH, Lecturer, Indonesia University
ClinicalTrials.gov Identifier: NCT04917458    
Other Study ID Numbers: 20-05-0484
First Posted: June 8, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by dr Rudi Putranto SpPD KPsi MPH, Indonesia University:
Diabetes Mellitus, Type 2
Depression
Cholecalciferol
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Depression
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents