Astudy to compare the daily versus monthly oral vitamin D3 in equivalent doses for treatment of vitamin D deficiency in infants.
Phase 3
- Conditions
- Health Condition 1: E40-E46- MalnutritionHealth Condition 2: E559- Vitamin D deficiency, unspecified
- Registration Number
- CTRI/2019/10/021549
- Lead Sponsor
- ady Hardinge Medical College Associated Hospital New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All infants (upto 12 months age) presenting with symptoms compatible with vitamin D
deficiency and documented to have serum vitamin D levels < 20ng/ml. These will include
infants with
- Hypocalcemic seizures
- Clinically & radiologically diagnosed rickets
Exclusion Criteria
-Infant with non â??nutritional rickets
-Infants having known comorbidities affecting vitamin D metabolism like: Diarrhea and
other mal-absorption syndromes, hepatic disorder , renal disorder, infants 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 comparing the proportion of subjects in <br/ ><br>in the 2 groups with <br/ ><br> -Complete normalisation of radiological score for healing of rickets, <br/ ><br>- Normalisation of serum ALP, calcium, Phosphate, PTH & serum 25(OH) D <br/ ><br>Timepoint: at one month, two month and three month after starting treatment <br/ ><br>
- Secondary Outcome Measures
Name Time Method The safety of the therapy will be estimated by measuring prevalence of the following <br/ ><br>Hypercalcemia, <br/ ><br>hypercalciurea and Hypervitaminosis DTimepoint: at 1month , 2 months and 3 months after starting treatment