MedPath

To study the effect of single bolus dose of Vitamin D supplementation given to lactating mothers on Vitamin D status in their breastfeeding infants at 30 days.

Phase 3
Registration Number
CTRI/2021/05/033888
Lead Sponsor
Dr Sampurnanand Medical College
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Healthy exclusively breastfed mother infant pairs(single term infants with weight more than 2 kg)within 1 month of delivary who will be willing to follow up after 1 month.

Exclusion Criteria

Mothers with preexisting comorbidities(type 2 diabetes,hypertension,chronic renal or liver disease),receiving antipsychotic drugs,clinical features suggestive of osteomalacia or severe Vitamin D deficiency,or exposure to medication known to interact with Vitamin D metabolism(steroids or anticonvulsants)

Infants with congenital malformation,history of severe birth asphyxia

Subjects with serum calcium more than 11mg/do,serum 25(OH)D level more than 100ng/ml,liver enzymes elevated more than 3 times of Upper limit normal and serum creatinine above upper limit normal for age.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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