Evaluation of treatment outcome among children of 1-10 years with Vitamin D deficiency treated with daily Vitamin D in comparison to fortnightly Vitamin D.
Not Applicable
- Conditions
- Health Condition 1: E559- Vitamin D deficiency, unspecified
- Registration Number
- CTRI/2021/02/031422
- Lead Sponsor
- Kumar Arghya Prasanna Mondal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All children 1-10 years of age presenting with symptoms compatible with
Vitamin D deficiency and documented to have serum Vitamin D levels < 20ng/ml. These will
include children with:
1. Clinically & radiologically diagnosed rickets
2. Tetany and hypocalcemic seizures
Exclusion Criteria
1. Children with suspected non â??nutritional rickets
2. Children having known comorbidities affecting Vitamin D metabolism like: celiac
disease and other mal-absorption states, chronic hepatic or renal disorder, children on
concomitant anticonvulsant therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of two treatment regimens will be assessed <br/ ><br>comparing the proportion of subjects in the 2 groups with: <br/ ><br>1. Complete normalization of radiological score (score 1.5) for healing of rickets. <br/ ><br>2. Normalization of serum ALP, Calcium, Phosphate, PTH & serum 25(OH) Vitamin D.Timepoint: At baseline, reevaluated at 4 weeks, 8 weeks, and at 12-13 weeks
- Secondary Outcome Measures
Name Time Method The safety of therapy will be estimated by measuring <br/ ><br>prevalence of the following in the 2 groups of subjects at various points of testing: <br/ ><br>1. Hypercalcemia: Total Ca (10.4 mg/dl), ionized calcium 5.32 mg/dl). <br/ ><br>2. Hypercalciuria: urinary calcium: creatinine ratio 0.21 <br/ ><br>3. Hypervitaminosis D: serum 25(OH) D 100 ng/ml.Timepoint: At 4 weeks, at 8 weeks, at 12-13 weeks