A Randomized controlled trial comparing two doses of vitamin D3 supplementation in human milk-fed preterm neonates

A Randomized trial comparing 2 doses of vitamin D3 supplementation in human milk-fed preterm neonates

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260620002

Enrollment

Registered

2026-06-20

Start date

2025-04-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Vitamin D insufficiency Vitamin D deficiency Preterm infant Low birth weight Vitamin D deficiency Vitamin D insufficiency Preterm infant Low birth weight Human milk

Interventions

Participants will receive vitamin D3 supplementation at a dose of 400 IU per day. Supplementation will be initiated at the start of trophic feeding 0.5 mL per day with a concentration of 800 IU per mL

Active Comparator Dietary Supplement,Experimental Dietary Supplement

Vitamin D3 400 IU per day,Vitamin D3 800 IU per day

Eligibility

Sex/Gender

All

Age

1 Days to No maximum

Inclusion criteria

Inclusion criteria: Preterm infants with gestational age <34 weeks and birth weight <1,800 grams, receiving human milk and/or donor human milk and admitted to the NICU, Queen Sirikit National Institute of Child Health during the study period from April 2025 to February 2026

Exclusion criteria

Exclusion criteria: 1. Infants whose mothers intend to feed formula milk 2. Infants with contraindications to breastfeeding, including maternal HIV infection or inborn errors of metabolism such as galactosemia 3. Infants with congenital gastrointestinal abnormalities, intestinal obstruction, or malabsorption disorders, including but not limited to omphalocele, gastroschisis, and cholestatic jaundice, or those requiring gastrointestinal surgery (e.g., duodenal atresia, jejunal atresia) 4. Infants with major congenital anomalies 5. Infants with chromosomal abnormalities 6. Infants with neuromuscular disorders 7.Infants with skeletal abnormalities or congenital fractures

Design outcomes

Primary

Measure	Time frame
Serum vitamin D sufficiency at 36 weeks postmenstrual age 36 weeks postmenstrual age serum vitamin D level less than 20 ng per mL	—

Secondary

Measure	Time frame
Vitamin D deficiency rate 36 weeks postmenstrual age Serum vitamin D level less than 20 ng per mL,vitamin D insufficiency rate 36 weeks postmenstrual age serum vitamin D level 20 - 30 ng per mL,Vitamin D intoxication rate 36 weeks postmenstrual age Serum vitamin D level greater than 100 ng per mL,Maternal and neonatal vitamin D correlation 36 weeks postmenstrual age Correlation between maternal and neonatal serum 25 hydroxyvitamin D levels measured in ng per mL,Preterm complication and vitamin D status During hospitalization until 36 weeks postmenstrual age Proportion of infants with respiratory distress syndrome necrotizing enterocolitis osteopenia of prematurity and culture proven sepsis stratified by vitamin D status	—

Measure

Time frame

Vitamin D deficiency rate 36 weeks postmenstrual age Serum vitamin D level less than 20 ng per mL,vitamin D insufficiency rate 36 weeks postmenstrual age serum vitamin D level 20 - 30 ng per mL,Vitamin D intoxication rate 36 weeks postmenstrual age Serum vitamin D level greater than 100 ng per mL,Maternal and neonatal vitamin D correlation 36 weeks postmenstrual age Correlation between maternal and neonatal serum 25 hydroxyvitamin D levels measured in ng per mL,Preterm complication and vitamin D status During hospitalization until 36 weeks postmenstrual age Proportion of infants with respiratory distress syndrome necrotizing enterocolitis osteopenia of prematurity and culture proven sepsis stratified by vitamin D status

—

Countries

Thailand

Contacts

Public ContactKanoklada Sagulsri

Queen Sirikit National Institute of Child Health

kanoklada11@hotmail.com0824880160

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026