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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02464865
Other study ID # Si656/2014
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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