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.

A Randomised Comparative Trial of two different bolus doses of Vitamin D given to lactating mother on serum Vitamin D levels of their infants.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033888

Enrollment

100

Registered

2021-05-31

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: 120000IU Vitamin D supplementation: Oral supplementation in form of 2 tablets each of 60000IU of Vitamin D Control Intervention1: 60000IU Vitamin D supplementation: oral supplementation

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To Compare the effectiveness of two different single bolus doses(120000IU and 60000IU)of maternal Vitamin D supplementation on Vitamin D status of their breastfeeding infants at 30 days.Timepoint: To Compare the effectiveness of two different single bolus doses(120000IU and 60000IU)of maternal Vitamin D supplementation on Vitamin D status of their breastfeeding infants at 30 days.	—

Secondary

Measure	Time frame
To find out the increase in maternal Vitamin D levels in mothers after 30 days of receiving Vitamin D supplementation of 120000IU or 60000IU as single doseTimepoint: 30 days;To study the proportion of Vitamin D deficiency in lactating mothers and their infants in a tertiary care hospital in a period of 12 monthsTimepoint: 12 months	—

Countries

India

Contacts

Public ContactPriyanka Dave

Dr. S.N.Medical College Jodhpur

jorarakesh@gmail.com9829012525

Outcome results