A clinical trial to study the short-term outcome of Vitamin-D supplementation to vitamin- D deficient patients requiring intensive care unit hospitalization.

Supplementation of single high dose Vitamin D in deficient critically ill children and assessment of their short-term outcome- An Open Label Randomized Control Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046556

Enrollment

100

Registered

2022-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Health Condition 1: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities Health Condition 2: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism Health Condition 3: I00-I99- Diseases of the circulatory system Health Condition 4: K00-K95- Diseases of the digestive system Health Condition 5: N00-N99- Diseases of the genitourinary system Health Condition 6: M00-M99- Diseases of the musculoskeletal system and connectiv

Interventions

Intervention1: SIngle high dose parenteral Vitamin D: 10,000IU/kg to max 4,00,000 IU vitamin D , orally or via nasogastric tube will be administered to critically ill children on day 1 of admission a

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1 month to 18 years, admitted in the Pediatric Intensive care unit with Serum Vitamin D level less than 30 ng/dL

Exclusion criteria

Exclusion criteria: 1. All the cases of Rickets (already diagnosed or diagnosed on this admission) 2. Patients admitted in the PICU for monitoring purpose like post operative cases, for performance of a procedure like lumbar puncture, bone marrow aspiration etc. 3. Patients who have received Vitamin D supplementation in the last 30 days. 4. Patients with abdominal pathology. 5. Patients requiring Intensive Care Unit stay less than 24 hours.

Design outcomes

Primary

Measure	Time frame
assessment of short term outcome of critically ill vitamin D deficiency children on supplementation of single high dose vitamin D.Timepoint: Day 1 of admission- Serum Vitamin D levels Day 1- Supplementation of single high dose vitamin D Day 3- urinary calcium creatinine ration Supplementation of vitamin d to the parallel group on discharge. End of the study- on discharge or mortality of the patient	—

Measure

Time frame

assessment of short term outcome of critically ill vitamin D deficiency children on supplementation of single high dose vitamin D.Timepoint: Day 1 of admission- Serum Vitamin D levels Day 1- Supplementation of single high dose vitamin D Day 3- urinary calcium creatinine ration Supplementation of vitamin d to the parallel group on discharge. End of the study- on discharge or mortality of the patient

—

Secondary

Measure	Time frame
Prevalence of vitamin D deficiency in critically ill childrenTimepoint: Day 1 of admission- Serum vitamin d level	—

Countries

India

Contacts

Public ContactDr Keta Vagha

Jawaharlal Nehru Medical College Sawangi (Meghe)

richa6101@gmail.com8390873476

Outcome results

None listed

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