Health Condition 1: N258- Other disorders resulting from impaired renal tubular function
Conditions
Interventions
Intervention1: Deksel Vitamin D3 60000 IU: Each subject will take 5ml of Cholecalciferol Vitamin D3 60000 IU Syrup every day for 10 days Thereafter from 15th day onwards a single 5ml dose of the same
Sponsors
Nizams Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age between 18 and 85 years 2 Those with an eGFR of greater than or equal to 15 and less than or equal to 59 mlmin1.73m2 CKD Grade 3 and 4 3 Serum total 25hydroxy D greater than or equal to 10 to less than or equal to 20 ng per ml 4 Plasma iPTH levels greater than or equal to 85 to less than 500 pg per ml 5 Serum Calcium of greater than or equal to 8.4 to less than 9.8 mg per dl 6 Serum Phosphorus of greater than or equal to 2 to less than 5 mg per dl 7 Patients are required to have language competency English Telugu or Hindi in order to complete the study related questionnaires which include the Beck Depression Inventory Questionnaire that measures characteristic attitudes and symptoms of depression 8 Normal Liver function test 9 A record will be made of the patients history and physical examination 10 Subject and legally acceptable representative LAR are able to attend all scheduled visits and to comply with all trial procedures 11 All patients will provide signed informed consent
Exclusion criteria
Exclusion criteria: 1 Not available for follow-up 2 Allergic to or intolerant to the investigational medication 3 Fasting Spot urinary Ca:Cr ratio greater than 0.2 4 Nephrotic range proteinuria greater than equal to 3.5 g per 24h urine 5 History of parathyroidectomy or renal transplantation 6 Subjects taking greater than 1000 mg per day of elemental Ca 7 Subjects receiving supplementation with ergocalciferol or cholecalciferol 8 Any bone metabolism therapy with the exception of bisphosphonates that could potentially interfere with study endpoints is to be discontinued for the duration of the study and a 56 day pre treatment washout is to be imposed In the case of bisphosphonates, subjects had to be on a stable dose for greater than 6 months prior to enrolment and maintain that dose for study duration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number or percent of subjects achieving mean percent reductions of plasma iPTH of greater than equal to 30 percent from pre treatment baseline at the end of the study Number of subjects with any adverse drug reaction Number of subjects with serum 25HydroxyD levels of greater than equal to 150 ng per ml Number of subjects with serum Ca levels of greater than equal to 10.5 mg per dl Number of subjects with serum P of greater than 5.0 mg per dlTimepoint: Screening Baseline Day 1 Day 30 Day 60 Day 90 Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number or percentage of individuals with a 25hydroxy D levels of greater than equal to 30 ng per ml Number or percentage of individuals requiring dose escalation after 3 months of treatment Number of deaths during the study periodTimepoint: Screening Baseline Day 1 Day 30 Day 60 Day 90 Day 180 | — |
Countries
India
Contacts
Public ContactDr D Sreebhushan Raju
Nizams Institute of Medical Sciences
Outcome results
None listed