Thiamin Deficiency in Obese Thai Children
1 other identifier
interventional
124
1 country
1
Brief Summary
This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Aug 2015
Typical duration for phase_4 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedOctober 2, 2018
September 1, 2018
2.9 years
May 18, 2015
September 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
abnormal thiamin pyrophosphate effect
Thiamin pyrophosphate effect will be measured by a blood test
7 days
Secondary Outcomes (1)
consumption of thiaminase-containing foods and thiamin antagonist-containing foods
7 days
Study Arms (3)
Thiamine 1
EXPERIMENTALpresence 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)
Non-thiamine
OTHERno symptoms and signs of thiamine deficiency
Thiamine 2
EXPERIMENTALpresence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)
Interventions
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
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
Eligibility Criteria
You may qualify if:
- obese : weight for height \> median + 3 standard deviations
- simple obesity
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Siriraj Hospital
Bangkok, 10700, Thailand
Related 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.
PMID: 23945419RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Narumon Densupsoontorn, MD
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2015
First Posted
June 8, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2018
Study Completion
August 1, 2018
Last Updated
October 2, 2018
Record last verified: 2018-09