Thiamin Deficiency in Obese Thai Children

Obesity Clinical Trial

Official title:

Thiamin Deficiency in Obese Thai Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464865
• Other study ID #: Si656/2014
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Beriberi
• Child
• Obesity
• Thiamine Deficiency

Intervention

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

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Densupsoontorn N, Jirapinyo P, Kangwanpornsiri C. Micronutrient deficiencies in obese Thai children. Asia Pac J Clin Nutr. 2013;22(3):497-503. doi: 10.6133/apjcn.2013.22.3.06. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abnormal thiamin pyrophosphate effect	Thiamin pyrophosphate effect will be measured by a blood test	7 days
Secondary	consumption of thiaminase-containing foods and thiamin antagonist-containing foods	Food diary and food frequency questionaire will be required to evaluate food consumption	7 days