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An observational study to define the normal organic acid levels in healthy Indian babies to help identify inherited metabolic disease at early stages.

Establishing organic acid profile in healthy Indian infants and generating warning and clinical decision cut offs indicative of metabolic disorders - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085814
Enrollment
300
Registered
2025-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: E889- Metabolic disorder, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

Anjal Maria
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Objective 1 and 2 Healthy neonates 3 days to 6 months exclusively breastfed and infants 6 months to 1 year Infants undergoing elective surgery and opting for biochemical analysis Inclusion Criteria for Objective 3 Infants with IEM spectrum diseases approximately n equals 10 complete enumeration of IEM cases diagnosed within 2 years

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Objective 1 and 2 Premature Infants Incomplete case records, Participants not willing to participate Exclusion Criteria for Objective 3 Critically ill infants or infants with active infections or communicable diseases or infants recovering from trauma or accidents or major surgeries

Design outcomes

Primary

MeasureTime frame
The study gives a complete normal organic acid profile in infants and base line reference values will be obtainedTimepoint: 3 years—

Secondary

MeasureTime frame
comparative data indicating organic acid levels in urine and bloodTimepoint: 3 years;normal reference ranges of organic acids and TCA cycle metabolitesTimepoint: 2.5 years;organic acid profile of diagnosed IEM patientsTimepoint: 3 years—

Countries

India

Contacts

Public ContactLeslie Edward Simon Lewis

Kasturba Medical College Manipal MAHE Manipal

leslie.lewis@manipal.edu9449208476

Outcome results

None listed

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