Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications Health Condition 2: E559- Vitamin D deficiency, unspecified
Conditions
Interventions
Intervention1: Vitamin D(cholecalciferol): 1. Dose, 60000 international units(IU)
2. Route of administration, oral
3. Frequency, one time in a week
4. Total Duratioin, for 12 weeks
Control Interventio
Sponsors
Dr Gaurav Singh Mehta
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 60 years 2. Diagnosed with Type 2 Diabetes Mellitus as per American Diabetes Association criteria a. Fasting Plasma Glucose more than or equal to 126 mg perdL (7.0 mmol perL) b. 2 hour Plasma Glucose (during OGTT) more than or equal to 200 mg perdL (11.1 mmol perL) c. HbA1C level more than or equal to 6.5 percent d. Random Plasma Glucose more than or equal to 200 mg perdL (11.1 mmol perL) with classic symptoms of hyperglycemia (polyuria, polydipsia, weight loss) or hyperglycemic crisis. 3. Clinically diagnosed Diabetic Neuropathy (symptomatic and or confirmed by nerve conduction studies) 4. Serum 25(OH) Vitamin D level less than 30 ng per mL (deficient or insufficient) 5. Willing to give informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Other causes of neuropathy (e.g alcohol abuse, hypothyroidism, renal failure, Vit B1, B6 or B12 deficiency) 2. Taking Vitamin D supplements within 3 months before enrollment 3. Severe hepatic or renal dysfunction 4. Pregnancy or lactation 5. Known hypersensitivity to study medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MNSI score, NTSS-6 score, and nerve conduction study parameters (velocity and amplitude) from baseline to 3 months after oral vitamin D supplementation.Timepoint: 3 months from the date of recruitment | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Gaurav Singh Mehta
Maharaja Agrasen Medical College, Agroha
Outcome results
None listed