Thiamin Deficiency in Obese Thai Children

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT02464865

Collaborator

(none)

124

Enrollment

Location

Arms

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity Child Thiamine Deficiency	Drug: Thiamine 1 Other: Non-thiamine Drug: Thiamine 2	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Thiamin Deficiency in Obese Thai Children

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thiamine 1 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)	Drug: Thiamine 1 If severe symptoms and signs of thiamine deficiency are present, thiamine is prescribed. Intervention 1 : severe symptom (heart failure, convulsion, or coma) : 50 mg thiamin administered very slowly intravenously, followed by a daily intramuscular dose of 10 mg for a week, and finally followed by 3-5 mg of thiamine per day orally for at least 6 weeks
Other: Non-thiamine no symptoms and signs of thiamine deficiency	Other: Non-thiamine no symptoms and signs of thiamine deficiency
Experimental: Thiamine 2 presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)	Drug: Thiamine 2 If symptoms and signs of thiamine deficiency are present, thiamine is prescribed. If mild symptom : a daily oral dose of 10 mg thiamin during the first week, followed by 3-5 mg of thiamin per day orally for at least 6 weeks

Arm

Intervention/Treatment

Experimental: Thiamine 1

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)

Drug: Thiamine 1

If severe symptoms and signs of thiamine deficiency are present, thiamine is prescribed. Intervention 1 : severe symptom (heart failure, convulsion, or coma) : 50 mg thiamin administered very slowly intravenously, followed by a daily intramuscular dose of 10 mg for a week, and finally followed by 3-5 mg of thiamine per day orally for at least 6 weeks

Other: Non-thiamine

no symptoms and signs of thiamine deficiency

Other: Non-thiamine

no symptoms and signs of thiamine deficiency

Experimental: Thiamine 2

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

Drug: Thiamine 2

If symptoms and signs of thiamine deficiency are present, thiamine is prescribed. If mild symptom : a daily oral dose of 10 mg thiamin during the first week, followed by 3-5 mg of thiamin per day orally for at least 6 weeks

Outcome Measures

Primary Outcome Measures

abnormal thiamin pyrophosphate effect [7 days]
Thiamin pyrophosphate effect will be measured by a blood test

Secondary Outcome Measures

consumption of thiaminase-containing foods and thiamin antagonist-containing foods [7 days]
Food diary and food frequency questionaire will be required to evaluate food consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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