Appropriate Dose of Vitamin D on Prevention of Osteopenia of Prematurity

Comparison of 400 U Vs 600 U daily on Prevention of Osteopenia of Prematurity in preterm newborns with gestational age below 32 week

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150423021910N7

Enrollment

108

Registered

2021-01-14

Start date

2020-10-22

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Osteopenia of prematurity. Osteoporosis, unspecified

Interventions

Intervention 1: Intervention group 1: Every 24 hours 25 drops equal to 1 cc of drop Vit D formulated in Alhavi Pharmacy company. Intervention 2: Intervention group 2: Every 24 hours 37 drops equal to

Eligibility

Sex/Gender

All

Age

1 Days to 35 Days

Inclusion criteria

Inclusion criteria: Preterm newborns with Gestational age below 32w Exclusive breast feeding Use of milk fortifier 1 gr per 25 cc of breast milk Reach of full enteral feeding during first 10 days of life Discontinue of TPN during first 10 days of life Normal Vitamin D level in Mothers during Pregnancy

Exclusion criteria

Exclusion criteria: Lack of perinatal Asphyxia Lack of IUGR Lack of Pre-Gestational and Gestational diabetes mellitus Lack of use of drugs interfere with Vitamin D metabolism

Design outcomes

Primary

Measure	Time frame
Total serum calcium. Timepoint: Five weeks after intervention. Method of measurement: colorimetery.;Serum phosphorus. Timepoint: Five weeks after intervention. Method of measurement: colorimetery.;Serum alkaline phosphatase. Timepoint: Five weeks after intervention. Method of measurement: colorimetery.;Radiographic changes of wrist. Timepoint: Five weeks after intervention. Method of measurement: Report of Radiologist.;Clinical symptoms of osteopenia. Timepoint: During study. Method of measurement: Clinical examination.	—

Measure

Time frame

Total serum calcium. Timepoint: Five weeks after intervention. Method of measurement: colorimetery.;Serum phosphorus. Timepoint: Five weeks after intervention. Method of measurement: colorimetery.;Serum alkaline phosphatase. Timepoint: Five weeks after intervention. Method of measurement: colorimetery.;Radiographic changes of wrist. Timepoint: Five weeks after intervention. Method of measurement: Report of Radiologist.;Clinical symptoms of osteopenia. Timepoint: During study. Method of measurement: Clinical examination.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Barekatain

Esfahan University of Medical Sciences

b_barekatain@med.mui.ac.ir+98 31 3261 6670

Outcome results

None listed

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