Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients
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|ClinicalTrials.gov Identifier: NCT04917458|
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : June 8, 2021
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|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)|
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.
|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|
-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
Placebo will be given to control group. It would be administrated orally, one capsule once a day for 30 days of study period
- 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.
- 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.
- 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.
- 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.
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
|Contact: Rudi Putrantoemail@example.com|
|Cipto Mangunkusumo National General Hospital||Recruiting|
|Jakarta Pusat, DKI Jakarta, Indonesia, 10430|
|Contact: Rudi Putranto +622131926052 firstname.lastname@example.org|
|Principal Investigator:||Rudi Putranto||Indonesia University|