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Effect of vitaminD supplementation on post operative surgical outcomes in children with cyanotic congenital heart disease undergoing open heart surgery: A Randomised Controlled trial

Effect of Vitamin D supplementation on outcome in children undergoing open heart surgery: A Randomised Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010827
Enrollment
100
Registered
2017-12-11
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

Health Condition 1: null- Pediatric (1mo to 12years) with congenital heart disease for elective surgical repair

Interventions

Intervention1: The Drug- Vitanin D(powdered form, sachets),to be administered orally with milk, single dose therapy, at a dose of 10000 IU/kg body weight and maximum dose not exceeding 400000 IU in to

Sponsors

No
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Transposition of Great Arteries 2.Total Anomalous Pulmonary Venous Connection 3.Tetralogy of Fallot 4.Tricuspid atresia 5.Univentricular Physiology 6.Shunts with reversal of flow 7. left to right shunts like ASD, VSD undergoing open heart surgery electively under cardiopulmonary bypass (CPB).

Exclusion criteria

Exclusion criteria: Urgent / emergency surgeries; syndromic children; closed heart surgeries ; preoperative infection/ antibiotic administration and ventilation

Design outcomes

Primary

MeasureTime frame
Post operative inotrope requirement(dose and duration0Timepoint: postoperative ICU course on day 1, 2,3—

Secondary

MeasureTime frame
Cardiac function evaluation on post op day1(ECHO), infection rate, ventilation duration , ICU and hospital stay. Vitamin D related adverse events (that is hypercalcemia, hypercalciuria) will be noted. Timepoint: Post operative course in ICU—

Countries

India

Contacts

Public ContactManoj Kumar sahu

AIIMS

drmanojsahu@gmail.com9911088705

Outcome results

None listed

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