Multi-dose Vitamin D Supplementation in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevention of Vitamin D Deficiency

NCT00494104

Vitamin D Deficiency

COMPLETED NA

Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA)

NCT03691896

Infant, Premature, Diseases

UNKNOWN PHASE3

Monitored vs Standard Supplementation of Vitamin D in Preterm Infants

NCT03087149

Vitamin D Deficiency Osteopenia Nephrolithiasis +1 more

COMPLETED NA

Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants

NCT01469650

Premature Infants

COMPLETED NA

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

NCT01812681

Respiratory Distress Syndrome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Vitamin D is a fat-soluble vitamin that is either taken by dietary sources or synthesized upon exposure to sun light. Although major function is on bone metabolism, in recent years other effects of Vitamin D attracted attention. Low neonatal vitamin D levels were reported to be associated with increased risk of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD) and sepsis.

Vitamin D level in the fetus and the newborn is mostly dependent on maternal vitamin D levels. Most of the vitamin D is transferred to the fetus during third trimester and as a result preterm newborns especially those with \<32 weeks gestational age are born with lower vitamin D stores. But there is no consensus regarding the adequate dose of vitamin D supplementation for preterm infants. The American Academy of Pediatrics recommends supplementation of 200-400 IU/d vitamin D for preterm infants. And the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends 800-1000 IU/d vitamin D supplementation for preterm infants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency Preterm Infants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Devit-3 Oral Drop 400 IU

supplemented with oral Vitamin D 400 IU/day (Devit-3 Oral Drop, 50000 IU/15 ml, Deva Company, Turkey) started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age

Group Type OTHER

Devit-3 Oral Drop

Intervention Type DRUG

Devit-3 Oral Drop 800 IU

Devit-3 Oral Drop 800 IU once daily by oral route started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age

Group Type ACTIVE_COMPARATOR

Devit-3 Oral Drop

Intervention Type DRUG

Devit-3 Oral Drop 1000 IU

Devit-3 Oral Drop1000 IU once daily by oral route started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age

Group Type ACTIVE_COMPARATOR

Devit-3 Oral Drop

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Devit-3 Oral Drop

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Preterm infants with gestational age 24 to 32 weeks who achieved at least 75% of total nutrition by enteral feedings in postnatal 2 weeks

Exclusion Criteria

* perinatal asphyxia,
* major congenital or chromosomal anomalies,
* those with no expectation of survival in first 2 weeks
* those that total parenteral nutrition was not ceased by the first 2 weeks

Minimum Eligible Age

24 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No