Effect of vitamin D on metabolic bone disease in preterm infants born to mothers with insufficient levels of vitamin D

Comparison of the effect of vitamin D with doses of 400 and 1000 units per day on biochemical and radiological indicators of metabolic bone disease in premature infants born to mothers with insufficient levels of vitamin D, a double-blind randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090813002342N14

Enrollment

Registered

2024-06-20

Start date

2024-06-21

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Neonatal metabolic bone disease. Transitory metabolic disturbance of newborn, unspecified

Interventions

Intervention 1: Intervention group 1: Preterm infants in this group receive 400 units per day of vitamin D (1 mL of oral drops of 400 IU/mL produced by the Ramopharmin company). Intervention 2: Interv

Eligibility

Sex/Gender

All

Age

1 Days to 14 Days

Inclusion criteria

Inclusion criteria: Premature infants with Gestational age < 34 weeks Age less than 14 days Birth weight less than 1800 g Born to mothers with insufficient levels of vitamin D

Exclusion criteria

Exclusion criteria: Infant suffering from chromosomal disorder syndromes Other bone metabolic diseases except rickets Having cholestasis Kidney dysfunction (increased serum creatinine equal to or more than 50% of normal)

Design outcomes

Primary

Measure	Time frame
Serum calcium. Timepoint: At the beginning of the study, 6 and 12 weeks later. Method of measurement: Spectrophotometer.;Serum phosphate. Timepoint: At the beginning of the study, 6 and 12 weeks later. Method of measurement: Spectrophotometer.;Serum alkaline phosphatase. Timepoint: At the beginning of the study, 6 and 12 weeks later. Method of measurement: Spectrophotometer.;Serum 25-hydroxyvitamin D3. Timepoint: At the beginning of the study, 6 and 12 weeks later. Method of measurement: Radioimmunoassay.	—

Measure

Time frame

Serum calcium. Timepoint: At the beginning of the study, 6 and 12 weeks later. Method of measurement: Spectrophotometer.;Serum phosphate. Timepoint: At the beginning of the study, 6 and 12 weeks later. Method of measurement: Spectrophotometer.;Serum alkaline phosphatase. Timepoint: At the beginning of the study, 6 and 12 weeks later. Method of measurement: Spectrophotometer.;Serum 25-hydroxyvitamin D3. Timepoint: At the beginning of the study, 6 and 12 weeks later. Method of measurement: Radioimmunoassay.

—

Secondary

Measure	Time frame
Examination of radiological indicators of bone. Timepoint: 6 and 12 weeks old. Method of measurement: X-ray of the left wrist.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamadreza rafati

Mazandaran University of Medical Sciences

mrrafati@mazums.ac.ir+98 11 3354 3084

Outcome results

None listed

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