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In moderate and late preterm newborns supplementation of postpartum mothers with vitamin D3 to achieve adequate levels of vitamin D in these newborns versus the routine supplementation of the newborns receiving Mothers Own Milk. A 3 month follow up randomized trial

Effect of High Dose Vitamin D3 Supplementation in Postpartum Mothers on Vitamin D Status of Moderate and Late Preterm babies receiving Mothers Own Milk. A 3 month Follow up Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052822
Enrollment
200
Registered
2023-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: E559- Vitamin D deficiency, unspecified

Interventions

Intervention1: High dose vitamin D3 to postpartum mothers of moderate and late preterm newborns: Mothers in this group will receive a high dose of vitamin D3 in the form of a cholecalciferol sachet- 1

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newborn babies of equal to or greater than 32 weeks of post-menstrual age till 37 completed weeks will be included with birth weight appropriate for gestational age as recorded on Fenton growth chart

Exclusion criteria

Exclusion criteria: The newborn will be excluded from the trial if they have- 1. Gross Congenital anomaly 2. With chromosomal anomaly 3. on formula feeds The mothers will be excluded if they are suffering from chronic diseases like tuberculosis, chronic liver disease, chronic kidney disease, HIV, hepatitis B, or those who have received vitamin D in the last 3 months apart from Tab Osteocalcium (elemental calcium 500 mg and vitamin D3 250 IU) given during the national antenatal program.

Design outcomes

Primary

MeasureTime frame
Serum 25(OH) vitamin D levelsTimepoint: at 12 weeks of postnatal age—

Secondary

MeasureTime frame
Maternal compliance with vitamin D3 therapyTimepoint: at 12 weeks of PostNatal Age;The proportion of children with- Biochemical Changes- 1) Hypocalcemia 2) Hypophosphatemia 3) Hypercalcemia 4 ) Raised serum alkaline phosphataseTimepoint: At 40 weeks of Postmenstrual age and at 12 weeks of Post Natal Age—

Countries

India

Contacts

Public ContactRavneet Kaur Saluja

AIIMS Jodhpur

drarunsingh61@yahoo.co.in8376079665

Outcome results

None listed

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