Back to resultsThiamin Deficiency in Obese Thai Children
Primary Purpose
Obesity, Child, Thiamine Deficiency
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Thiamine 1
Non-thiamine
Thiamine 2
Sponsored by
About this trial
This is an interventional screening trial for Obesity focused on measuring thiamine deficiency, obese children, Thai
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Experimental
Arm Label
Thiamine 1
Non-thiamine
Thiamine 2
Arm 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)
no symptoms and signs of thiamine deficiency
presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)
Outcomes
Primary Outcome Measures
abnormal thiamin pyrophosphate effect
Thiamin pyrophosphate effect will be measured by a blood test
Secondary Outcome Measures
consumption of thiaminase-containing foods and thiamin antagonist-containing foods
Food diary and food frequency questionaire will be required to evaluate food consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02464865
Brief Title
Thiamin Deficiency in Obese Thai Children
Official Title
Thiamin Deficiency in Obese Thai Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Child, Thiamine Deficiency
Keywords
thiamine deficiency, obese children, Thai
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thiamine 1
Arm Type
Experimental
Arm 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)
Arm Title
Non-thiamine
Arm Type
Other
Arm Description
no symptoms and signs of thiamine deficiency
Arm Title
Thiamine 2
Arm Type
Experimental
Arm Description
presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)
Intervention Type
Drug
Intervention Name(s)
Thiamine 1
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Non-thiamine
Intervention Description
no symptoms and signs of thiamine deficiency
Intervention Type
Drug
Intervention Name(s)
Thiamine 2
Intervention Description
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
Primary Outcome Measure Information:
Title
abnormal thiamin pyrophosphate effect
Description
Thiamin pyrophosphate effect will be measured by a blood test
Time Frame
7 days
Secondary Outcome Measure Information:
Title
consumption of thiaminase-containing foods and thiamin antagonist-containing foods
Description
Food diary and food frequency questionaire will be required to evaluate food consumption
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narumon Densupsoontorn, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
23945419
Citation
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.
Results Reference
result
Learn more about this trial
Thiamin Deficiency in Obese Thai Children
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