Trial Outcomes & Findings for Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities (NCT NCT01812681)

NCT ID: NCT01812681

Last Updated: 2014-08-15

Results Overview

The association of vitamin D level with respiratory distress syndrome

• Recruitment status: COMPLETED
• Target enrollment: 81 participants
• Primary outcome timeframe: three days
• Results posted on: 2014-08-15

Participant Flow

Participant milestones

Measure	Low Vitamin D Level The premature infants with low cord blood vitamin D level	Normal Vitamin D The premature infants with normal vitamin D level
Overall Study STARTED	60	24
Overall Study COMPLETED	57	24
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities

Baseline characteristics by cohort

Measure	Low Vitamin D Level n=57 Participants The premature infants with low cord blood vitamin D level	Normal Vitamin D n=24 Participants The premature infants with normal vitamin D level	Total n=81 Participants Total of all reporting groups
Age, Continuous	27.9 weeks STANDARD_DEVIATION 2.4 • n=5 Participants	29.2 weeks STANDARD_DEVIATION 1.8 • n=7 Participants	28.3 weeks STANDARD_DEVIATION 3.6 • n=5 Participants
Age, Categorical <=18 years	57 Participants n=5 Participants	24 Participants n=7 Participants	81 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	12 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	12 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment Turkey	57 participants n=5 Participants	24 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: three days

The association of vitamin D level with respiratory distress syndrome

Outcome measures

Measure	Low Vitamin D Level n=57 Participants The premature infants with low cord blood vitamin D level	Normal Vitamin D n=24 Participants The premature infants with normal vitamin D level
Respiratory Distress Syndrome	52 participants	3 participants

SECONDARY outcome

Timeframe: four weeks

Association of vitamin D level with sepsis

Outcome measures

Measure	Low Vitamin D Level n=57 Participants The premature infants with low cord blood vitamin D level	Normal Vitamin D n=24 Participants The premature infants with normal vitamin D level
Sepsis	18 participants	3 participants

Adverse Events

Low Vitamin D Level

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Serdar Beken

Dr. Sami Ulus Children's Hospital

Phone: 00903123056449

Email: serbeken@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place