Evaluation of effect of different type of vitamin D on biochemical markers of osteopenia of Prematurity
Phase 3
- Conditions
- metabolic bone disease in very low birth weight infants.decreased bone mineral content relative to the expected level of mineralization seen in conjunction with biochemical and/or radiographic changes
- Registration Number
- IRCT20111206008307N28
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Inborn Very low birth weight infants (<1500g) in Alzahra Teaching hospital
Taking consent of parents
Tolerating 120cc/kg/day breast milk or breast milk with formula ( Full feed )
Exclusion Criteria
Infants with major malformation
Infants with congenital cardiac disease
Infants with familial history of bone disease
Infants receiving corticosteroids
Infants born from mothers with renal failure
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemical markers of Osteopenia Prematurity including :ALP , P , Ca. Timepoint: Biochemical marker measurement at baseline , 3 and 6 weeks later starting treatment and before discharge. Method of measurement: Rochas.Anzimatic method by Selectra auto analyzer.;Serum Vit D3 Level. Timepoint: At baseline , 3 and 6 weeks later after treatment and before discharge. Method of measurement: Electrochemiluminescence method by Alexis.;Serum parathormon level. Timepoint: Biochemical marker measurement at baseline , 3 and 6 weeks later after treatment and before discharge. Method of measurement: serum level of parathormon hormon is measured with electrochemiluminescence method by Alexis Rochas.
- Secondary Outcome Measures
Name Time Method Calculation of Tubular reabsorption of phosphate. Timepoint: At the binning of the study , 3 ,6 weeks after treatment and before discharge. Method of measurement: TRP = 1-(Urine phosphate x Pcreatinine/ Pphosphate x U creatinine).