Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe)
Conditions
Interventions
Intervention1: Vitamin D: 600000 IU Vitamin D intramuscular injection administered at baseline and at 6 months. Duration of therapy-six months.
Control Intervention1: Placebo: 1 ml Normal saline intr
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry
Eligibility
Inclusion criteria
Inclusion criteria: South Indian non-diabetic CKD stage 3 and 4 patients with vitamin D Deficiency ( < 20 ng/ml).
Exclusion criteria
Exclusion criteria: Symptoms of vitamin D deficiency such as fractures, Patients with peanut allergy, Severe Vitamin D deficiency (Vitamin D level < 5 ng/ml), Pregnant or lactating women, Patients who received steroids in the last 6 months, Immobilization of 3 months, Inherited disease of bone, Malignancy, Therapeutic Vitamin D supplementation for last one month, Neoplasia or infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone specific alkaline phosphatase (BALP) and Flow-mediated dilatation (FMD)Timepoint: 6th month and 12th month | — |
Secondary
| Measure | Time frame |
|---|---|
| Calcium, Phosphorous,Alkaline phosphatase, Urinary calcium creatinine ratio,Total 25-hydroxyvitamin D,Parathyroid hormone, FGF-23, klotho, carboxy-terminal telopeptide-1,ADMA, BMD, fractures, reaching GFR less than 15 ml/min, fall in GFR more than 15 ml/min or End Stage Renal Disease, Ischemic Heart Disease, cerebrovascular accidents or stroke or peripheral vascular disease, Genetic Variations in SNPs of the GC, VDR, CASR, CYP24A1 genes.Timepoint: 6th month and 12th month | — |
Countries
India
Contacts
Public ContactMs G Priyadarshini
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Outcome results
None listed