Evaluation of effect of different type of vitamin D on biochemical markers of osteopenia of Prematurity

Comparison of Calcitriol and Cholecalciferol on biochemical markers of Metabolic Bone Disease in very low birth weight infants

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20111206008307N28

Enrollment

Registered

2018-06-10

Start date

2017-05-22

Completion date

Unknown

Last updated

2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Intervention 1: Intervention group: calcitriol group receives calcitriol 0.2 µg/kg/day ( From calcitriol pearl's content pooled in insulin syringe). Infants receives calcitriol during feeding with

Eligibility

Sex/Gender

All

Age

14 Days to 28 Days

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTaher entezar maleki

Tabriz University of Medical Sciences

Deanpharmacy@tbzmed.ac.ir+98 41 3337 2250

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026