Thiamin Deficiency in Obese Thai Children

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Thiamine Deficiency; Child; Obesity

Treatments: Other: Non-thiamine; Drug: Thiamine 2; Drug: Thiamine 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02464865

Si656/2014

Details and patient eligibility

About

This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.

Full description

This study is a cross-sectional study. The objectives of the study are to determine the prevalence of thiamin deficiency in obese Thai children and to assess the associations of dietary factors and thiamin deficiency.

Enrollment: 124 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• obese : weight for height > median + 3 standard deviations
• simple obesity

Exclusion criteria

• pathological obesity
• chronic diseases e.g. cerebral palsy, metabolic disease, etc.
• diseases of red blood cells
• on medication e.g. steroid, multivitamins, thiamine-containing vitamins, diuretic drugs
• hemodialysis or peritoneal dialysis
• bariatric surgery

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

124 participants in 3 patient groups

Thiamine 1

Experimental group

Description:

presence of severe symptoms and signs of thiamine deficiency: heart failure, convulsion, coma, loss of ankle and knee jerks with muscular wasting and paralysis (typically symmetrical foot- and wrist-drop)

Treatment:

Drug: Thiamine 1

Non-thiamine

Other group

Description:

no symptoms and signs of thiamine deficiency

Treatment:

Other: Non-thiamine

Thiamine 2

Experimental group

Description:

presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)

Treatment:

Drug: Thiamine 2