Oral Vitamin D supplementation with 800IU versus 400IU in improving serum Vitamin D levels among term breastfed Small for Gestational Age neonates

Efficacy of daily oral Vitamin D3 supplementation with 800IU versus 400 IU in improving serum Vitamin D levels among term breastfed Small for Gestational Age neonates at 14 weeks postnatal age: An Open label Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057291

Enrollment

Registered

2023-09-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: P051- Newborn small for gestational age

Interventions

Intervention1: 800IU oral Vitamin D3 supplementation: 800IU oral Vitamin D3 supplementation after enrolment within 7 days Control Intervention1: 400IU oral Vitamin D3 supplementation: 400IU oral Vitam

Eligibility

Inclusion criteria

Inclusion criteria: Term gestation and exclusively breastfed Small for Gestational Age neonates

Exclusion criteria

Exclusion criteria: Presence of lethal congenital malformations/chromosomal abnormalities, Need for NICU admission > 7 days, Mothers on anticonvulsant or antitubercular drugs

Design outcomes

Primary

Measure	Time frame
Serum 25 hydroxy Vitamin D levelsTimepoint: 14 weeks postnatal age	—

Secondary

Measure	Time frame
Clinical ricketsTimepoint: 14 weeks postnatal age;HypercalcemiaTimepoint: 14 weeks postnatal age;HyperparathyroidismTimepoint: 14 weeks postnatal age;RehospitalisationTimepoint: 14 weeks postnatal age;Respiratory morbiditiesTimepoint: 14 weeks postnatal age;Severe Vitamin D deficiencyTimepoint: 14 weeks postnatal age;Vitamin D deficiencyTimepoint: 14 weeks postnatal age;Vitamin D insufficiencyTimepoint: 14 weeks postnatal age;Vitamin D toxicityTimepoint: 14 weeks postnatal age	—

Measure

Time frame

Clinical ricketsTimepoint: 14 weeks postnatal age;HypercalcemiaTimepoint: 14 weeks postnatal age;HyperparathyroidismTimepoint: 14 weeks postnatal age;RehospitalisationTimepoint: 14 weeks postnatal age;Respiratory morbiditiesTimepoint: 14 weeks postnatal age;Severe Vitamin D deficiencyTimepoint: 14 weeks postnatal age;Vitamin D deficiencyTimepoint: 14 weeks postnatal age;Vitamin D insufficiencyTimepoint: 14 weeks postnatal age;Vitamin D toxicityTimepoint: 14 weeks postnatal age

—

Countries

India

Contacts

Public ContactSudarshan J

Atal Bihari Vajpayee Institute of Medical Sciences & Dr Ram Manohar Lohia hospital

bhawnasd@yahoo.com9811520862

Outcome results

None listed

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