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Comparison of the efficacy of two doses of Vitamin D supplementation to prevent Vitamin D deficiency in healthy term breastfed infants.

Efficacy of 800 IU versus 400 IU per day of oral Vitamin D3 supplementation on Vitamin D sufficiency in healthy, breastfed infants: A Randomized Controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017374
Enrollment
92
Registered
2019-02-01
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: 800 IU/day oral Cholecalciferol: Cholecalciferol drops 800 IU/day orally till 14 week post-natal age Control Intervention1: 400 IU per day oral cholecalciferol: Cholecalciferol drops 40

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inborn healthy, term, singleton, appropriate for gestation age (as defined by Fentonâ??s growth charts) infants will be included.

Exclusion criteria

Exclusion criteria: 1) Birth weight 2) Multiple pregnancy 3) Families from far off places, and not willing for follow up. 4) Mother or infant on anticonvulsant or anti-tubercular treatment 5) Major congenital malformations 6) Severe birth asphyxia (APGAR 7) Need for NICU stay for >48 hours

Design outcomes

Primary

MeasureTime frame
Proportion of infants with Vitamin D insufficiency- Number of babies with Vitamin D levels less than20 ng/mlTimepoint: 14 weeks postnatal age—

Secondary

MeasureTime frame
1. Prevalence of Vitamin D insufficiency at birth in term neonates. 2. Serum Calcium, phosphorous, ALP 3. Frequency of morbidities- Number of episodes of respiratory morbidity or hospitalizationTimepoint: 14 weeks postnatal age—

Countries

India

Contacts

Public ContactDR BHARTI

AIIMS Jodhpur

neerajpgi@yahoo.co.in8003996908

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 17, 2026