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comparison of two doses of vitamin D in healthy term neonates

COMPARISON OF EFFICACY OF DAILY SUPPLEMENTATION OF 800 IU vs. 400 IU VITAMIN D ON SERUM VITAMIN D STATUS AT 14 WEEKS OF AGE IN TERM HEALTHY NEONATES: A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029281
Enrollment
108
Registered
2020-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: vitamin D 800 IU per day: Vitamin D supplementation will be started at discharge and continued till 14 weeks postnatal age. Before hospital discharge, families will receive written inst
will be recorded for all the babies. The baby will be assessed for possible symptoms of Vitamin D toxicity (nausea, recurrent vomiting, poor feeding, abdominal pain, polydipsia, anorexia o

Sponsors

PGIMER CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Gestational age 37 weeks or more 2) Appropriate for gestation age (as defined by Intergrowth 21 growth charts) (32)

Exclusion criteria

Exclusion criteria: 1) Families are not willing to follow-up at PGIMER. 2) Mother or infant on medications which can affect vitamin D metabolism (33) (Annexure-VII) 3) Mother is a known case of Chronic renal failure/ chronic liver failure/Parathyroid disorders 4) Major congenital malformations 5) Severe birth asphyxia (As defined by AAP/ACOG or need for chest compression) 6) Enteral feeding is not established by 48 hours of life.

Design outcomes

Primary

MeasureTime frame
to compare proportions of vitamin D insufficieny in two groupsTimepoint: 14 weeks postnatal age

Secondary

MeasureTime frame
1. Incidence of maternal and neonatal vitamin D deficiency and insufficiency 2. To compare the proportion of Vitamin D deficiency; biochemical parameters (serum Calcium, Phosphorous, ALP, PTH), anthropometry (Weight, Length, and Occipitofrontal circumference), adverse events related to vitamin D toxicity, and frequency of morbidities (episodes of respiratory illness, Hospitalization, seizure, etc) Timepoint: Outcome 1 at birth and rest at 14±2 weeks postnatal age

Countries

India

Contacts

Public ContactJogender Kumar

PGIMER Chandigarh

jogendrayadv@gmail.com0172-2755318

Outcome results

None listed

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