| Trial ID: | L4097 |
| Source ID: | NCT04917458
|
| Associated Drug: |
Cholecalciferol 4000 Iu Oral Capsule, Liquid Filled
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| Title: |
Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients
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| Acronym: |
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| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Diabetes Mellitus, Type 2|Depressive Symptoms
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| Interventions: |
DRUG: Cholecalciferol 4000 IU Oral Capsule, Liquid Filled|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: Evaluating the effects of cholecalciferol against neuroplasticity (NT-3), 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., 30 days|Evaluating the effects of cholecalciferol against serotonin, 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., 30 days|Evaluating the effects of cholecalciferol against C-Peptide, 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., 30 days
|
| Sponsor/Collaborators: |
Sponsor: Indonesia University
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
90
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2021-01-18
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| Completion Date: |
2021-10
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| Results First Posted: |
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| Last Update Posted: |
2021-06-08
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| Locations: |
Cipto Mangunkusumo National General Hospital, Jakarta Pusat, DKI Jakarta, 10430, Indonesia
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| URL: |
https://clinicaltrials.gov/show/NCT04917458
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