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Study on vitamin D effect in Severe acute malnutrition children with complication

Effect of Vitamin D Therapy in children with Severe Acute Malnutrition With Medical complication:An Open Label Randomised Controlled Trail.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024435
Enrollment
100
Registered
2020-04-01
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: E43- Unspecified severe protein-caloriemalnutrition

Interventions

Intervention1: Vitamin D3: 60000IU Vitamin D3 orally weekly for 6 week along with standard therapy for SAM (except vitamin D ) for 2 weeks. Control Intervention1: SAM supplements: SAM supplements is g

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with severe acute malnutrition with medical complication with vitamin D3 level less than 20ng/ml.

Exclusion criteria

Exclusion criteria: Children undergoing treatment for vitamin D deficiency(Rickets) or received vitamin D therapy in the last 3 months. Children suffering from chronic systemic diseases ie. secondary cases of SAM(any chronic Renal, cardiac, hepatic, neurological or developmental and major anomalies/surgical cases. Children suffering from known malabsorption disease like celiac disease, malabsorption syndromes, cardiac failure. Children suffering from known metabolic bone disease. Children on anticonvulsants or any other medication interfere with cytochrome P450 activities.

Design outcomes

Primary

MeasureTime frame
Proportion of children with mean weight for height Z score more than 0.5 SD from base line at the end of 8 week in both groups.Timepoint: 8 week

Secondary

MeasureTime frame
Propotion of children with weight gain more than 15% from base at the end of 8 weeks in both groups. Proportion of children having recurrent infections and severe infections at the end of 8 weeks. Level of vitamin D in both groups at the end of 8 week.Timepoint: 8 week

Countries

India

Contacts

Public ContactSrikanta Basu

kalawati saran children hospital

srikantabasu@gmail.com9818291595

Outcome results

None listed

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