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Assess the effect of Monthly versus daily vitamin D supplementation in children with chronic kidney disease stages 3 to 5 on vitamin d level and bone health markers

Intermittent versus daily vitamin D supplementation in children with chronic kidney disease stages 3 to 5 – A Non-Inferiority Trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077994
Enrollment
234
Registered
2024-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: monthly vitamin d: monthly vitamin D 60000iu every month for 6 months duration Control Intervention1: daily vitamin D: Daily vitamin D supplementation 2000iu for 6 months duration

Sponsors

Pujitha Vallabhaneni
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 1 to 14 years CKD with eGFR less than 60ml/1.73m2/hr Children with vitamin D levels between 12 to 50ng/ml Patient willing to give written informed consent

Exclusion criteria

Exclusion criteria: •Vitamin D levels of more than 100ng/ml or hypercalciuria or nephrocalcinosis or hypercalcemia, or suppressed iPTH •Not willing to come for follow-up at 3 months and 6 months

Design outcomes

Primary

MeasureTime frame
Compare 25 hydroxy vitamin D levelsTimepoint: Baseline, 12 weeks, 24 weeks

Secondary

MeasureTime frame
Urine spot calcium creatinine ratio, USG KUB for nephrocalcinosisTimepoint: baseline, 24 weeks;Estimated GFRTimepoint: Baseline, 12week, 24 weeks;Level of BSALP TRACP-5b CTX – ITimepoint: Baseline, 24 week;Bone mineral density measured by DEXATimepoint: Baseline, 24 weeks;Level of serum calcium, phosphate, iPTHTimepoint: Baseline, 12 weeks, 24 weeks

Countries

India

Contacts

Public ContactDr Lesa Dawman

PGIMER Chandigarh

vallabhanenipujitha143@gmail.com9618221731

Outcome results

None listed

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