Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Vitamin D: Vitamin D 6000 IU once weekly for a maximum period of 16 weeks
Control Intervention1: Donepezil: Donepezil 5mg once daily for a maximum period of 16 weeks
Sponsors
Dr R Praveenkumar
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 diabetes mellitus on treatment Vitamin D
Exclusion criteria
Exclusion criteria: 1.Severe complications of diabetes (amputation, blindness, and dialysis) 2. Reduced kidney function (GFR 3.History of kidney stones (unless origin known to be not calcium), 4.History of neurological diseases (Stroke, TIA, or lacunar infarct, Parkinsonâ??s Disease, Severe Brain Injury, Multiple Sclerosis, Meningitis, Brain Infection, Epilepsy, Any sensory or motor disorder that would preclude psychological testing including blindness) 5.History of Psychiatric Illness (bipolar depression or psychosis, Schizophrenia) 6.History of Hypothyroidism, Electrolyte disturbances. 7.History of consumption of drugs which have psychoactive effects such as Benzodiazepines, Tranquilizers, Anti-depressants 8.Current alcohol or substance use disorder. 9.History of Severe Renal or Hepatic Impairment or any critical illness. 10.Breast feeding, pregnant, or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to compare change in executive functioning (attention, inhibition, working memory, Orientation) through Montreal Cognitive Assessment Scale between treatment groupsTimepoint: 0 30 days 60 days 90 days and 120 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The secondary outcome is to assess Quality of Life through WHO Quality of Life Questionnaire between two treatment groups 2.To Evaluate Glycaemic Control by assessing HbA1C between two treatment groups Timepoint: 0 and 120 days | — |
Countries
India
Contacts
Public ContactPRAVEENKUMAR RAJENDRAN
SRM MEDICAL COLLEGE & RESEARCH CENTRE
Outcome results
None listed