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Effect of vitamin D supplementation in term infants

Effect of Vitamin D Supplementation in Healthy Term Infants: A Randomized Double-Blinded Placebo Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240405002
Enrollment
68
Registered
2024-04-05
Start date
2020-07-16
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

Effect of vitamin D supplementation on healthy term newborns Vitamin D deficiency, vitamin D supplementation, newborn

Interventions

Vitamin D syrup (400 IU/mL), 1 mL/day orally, OD, from recruit until 6 months of age,Dextrose syrup, 1 mL/day orally, OD, from recruit until 6 months of age
Experimental Drug,Placebo Comparator Other

Sponsors

Navamindradhiraj Research Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Days to 3 Days

Inclusion criteria

Inclusion criteria: 1. Born at term (gestational age 37-42 weeks), 2. Normal weight for age (2500-4000 g), 3. No perinatal asphyxia event (Apgar score at 5 mins >7), 4. Maternal aged between 18-35 years old with no known medical conditions

Exclusion criteria

Exclusion criteria: 1. Taking certain medications effect vitamin D level such as steroids, antiepileptic drugs, 2. Newborn diagnosed with intrauterine growth retardation, chromosome abnormalities, congenital anomalies, sepsis, 3. Admitted to neonatal intensive care unit

Design outcomes

Primary

MeasureTime frame
Vitamin D status At 6 months of age nanogram per mL / serum 25-(OH)D

Secondary

MeasureTime frame
Side effect At 2 months, 4 months and 6 months of age Interview patient,side effect (vitamin D toxicity) At 6 months of age mg/dL / serum calcium and phosphorus

Countries

Thailand

Contacts

Public ContactSupapan Tantracheewathorn

Navamindradhiraj University

supapan.t@nmu.ac.th66892358874

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026