Effects of vitamin D and magnesium co-supplementation in patients with type 2 diabetes

Phase 3

Recruiting

Conditions: Type 2 diabetes.
Type 2 diabetes mellitus with neurological complications
E11.4

Registration Number: IRCT20090901002394N50

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

Willing to participate and signing informed consent
Diagnosis of diabetes by a specialist
Stable blood glucose level defined by HbA1C< 8.5%
Age 40-65
Patients who are currently under medication therapy
At least 5 years history of type 2 diabetes

Exclusion Criteria

Having severe complications of diabetes such as amputation, blindness and dialysis
Patients with malabsorption syndromes
History of stroke, transient ischemic attack and lacunar infarction
Patients with severe depression and anxiety, bipolar and psychosis
Loss of consciousness for more than 5 minutes
Having dementia, Parkinson's, schizophrenia, Huntington's, AIDS, HIV positive
Patients with chronic diseases such as liver failure, thyroid diseases and cancer.
Alcohol, smoking and drug use
Pregnant and lactating women or women who intend to become pregnant
Taking drugs affecting the CNS
Any change in the patient's medicine or its dosage during the last 3 months before the trial
Regular consumption of higher than RDA doses of magnesium and vitamin D supplements and other supplements during the 2 months prior to the intervention
Taking medicine containing magnesium more than 150 mg

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive function. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: MoCA (Montreal Cognitive Assessment) test.;Executive function. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Verbal fluency test.;Verbal memory. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Auditory Verbal Learning Test.;Attention. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Stroop Color and Word Test.;Information processing speed. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Stroop Color and Word Test.;CRP (C-Reactive Protein) level. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Laboratory test.

Secondary Outcome Measures

Name	Time	Method
FBS. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Laboratory test.;HbA1c. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Laboratory test.;25 (OH) Vit D. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Laboratory test.;Blood pressure. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: sphyngomanometer.;Body composition. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: scale.