SUBLINGUAL SUGAR FOR THE TREATMENT OF HYPOGLYCEMIA AMONG CHILDREN WITH SEVERE ACUTE MALNUTRITION

THE EFFECT OF SUBLINGUAL SUGAR FOR THE TREATMENT OF HYPOGLYCEMIA AMONG CHILDREN WITH SEVERE ACUTE MALNUTRITION ADIMITTED TO REFFERRAL HOSPITALS IN AMHARA REGION, NORTHWEST ETHIOPIA,2020: A NON-INFERIORITY RANDOMIZED CLINICAL TRIAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202110635504187

Enrollment

140

Registered

2021-10-13

Start date

2021-11-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Nutritional, Metabolic, Endocrine

Interventions

sublingual sugar

IVorNG

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children admitted to the study hospitals will be eligible if they are --aged 6–59 months, --have Severe Acute Malnutrition --with hypoglycemia (blood glucose concentration (BGC) < 54 mg/dl , < 3 mmol/l), -- are in a condition that would need an IVG or alternative treatment for the same indication: lethargic, unconscious, or convulsing or repeated vomiting; or if they are alert but unable to drink. --and if families or caregivers provide oral and/or written informed consent .

Exclusion criteria

Exclusion criteria: Children will be excluded if they are --able to drink properly and do not need IVG. This means children whose blood glucose can be raised through drinking sugary liquid. --have congenital anomalies such as congenital heart disease, physical deformities, --known diabetes, hemophilia or history of neonatal hypoglycemia, --critically ill (such as dying children, children with chock or premortem dyspnea etc) --unable to give blood sample --had been previously enrolled in the study. --have parents or guardians who did not give consent

Design outcomes

Primary

Measure	Time frame
Reaching a normal glucose concentration over 60 mg/dl after in 40 minutes. Significant blood glucose gain (> 10 mg/dl) in 40 minutes	—

Secondary

Measure	Time frame
? Time to normal glycemia: defined as the time to the first normal glycemia ? Time to become alert, time to able to drink ? Relapse, defined as children who reached a normal glycaemia 3.3 mmol/L (60 mg/dl), but failed to maintain during the study period. Early relapse is before 40 minutes and late relapse between 40 and 120 minutes ? Maximal blood glucose concentration (BGC) gain (CGmax), defined as the peak serum glucose concentration within the first line treatment of the first 40 minutes minus the baseline serum glucose concentration ? Sustain CGmax defined as the difference between serum glucose concentration at the end of study (2 hours) and the baseline serum glucose concentration ? Tolerance and side effects	—

Measure

Time frame

? Time to normal glycemia: defined as the time to the first normal glycemia ? Time to become alert, time to able to drink ? Relapse, defined as children who reached a normal glycaemia 3.3 mmol/L (60 mg/dl), but failed to maintain during the study period. Early relapse is before 40 minutes and late relapse between 40 and 120 minutes ? Maximal blood glucose concentration (BGC) gain (CGmax), defined as the peak serum glucose concentration within the first line treatment of the first 40 minutes minus the baseline serum glucose concentration ? Sustain CGmax defined as the difference between serum glucose concentration at the end of study (2 hours) and the baseline serum glucose concentration ? Tolerance and side effects

—

Countries

Ethiopia

Contacts

Public ContactAnneLaure Cavin

Scientific followup

alcavin@antenna.ch141227371242

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026