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Effect of vitamin D supplementation to mothers on vitamin D status of exclusively breastfed infants

Vitamin D supplementation to mothers during lactation : Effect on vitamin D levels of exclusively breastfed infants at 6 months - A randomized triple blind placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/10/007333
Enrollment
132
Registered
2016-10-04
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 D3 [25(OH)D3]: Lactational mothers will be given vitamin D3 at postpartum, at 6 weeks, at 10 weeks and at 14 weeks and serum vitamin D3 levels will be measured in exclusively br

Sponsors

UCMS and GTB HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: consecutive born singleton exclusively breastfeeding full term babies of both sexes and their mothers

Exclusion criteria

Exclusion criteria: Neonatal characteristics: small for gestation and large for gestation, congenital anomalies or suspicion of chromosomal and endocrinological disorders, babies suffered from birth asphyxia, hypocalcaemia, hypoglycemia, respiratory distress at birth, sepsis, intracranial infection who are undergoing exchange blood transfusion who have received vitamin D Maternal charactics: suffering from chronic illnesses like tuberculosis, diabetes mellitus, chronic liver disease, chronic kidney disease, severe anaemia, HIV positive, hepatitis B positive mothers with gestational diabetes mellitus, pregnancy induced hypertension suffering from endocrinological disorders who have received vitamin D within last 3 months

Design outcomes

Primary

MeasureTime frame
proportion of exclusively breastfed babies having serum 25(OH)vitamin D3 levels less than 11 ng/ml at 6 months of age in both the groupsTimepoint: at 6 months

Secondary

MeasureTime frame
proportion of babies developing radiological rickets at 6 months in both the groups, proportion of babies developing biochemical rickets at 6 months in both the groupsTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Maharshi Trivedi

UCMS and GTB hospital

mmafaridi@yahoo.co.in9868399740

Outcome results

None listed

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