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Thiamin Deficiency in Obese Thai Children

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ClinicalTrials.gov Identifier: NCT02464865
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Tracking Information
First Submitted Date  ICMJE May 18, 2015
First Posted Date  ICMJE June 8, 2015
Last Update Posted Date October 2, 2018
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2015)
abnormal thiamin pyrophosphate effect [ Time Frame: 7 days ]
Thiamin pyrophosphate effect will be measured by a blood test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2015)
consumption of thiaminase-containing foods and thiamin antagonist-containing foods [ Time Frame: 7 days ]
Food diary and food frequency questionaire will be required to evaluate food consumption
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thiamin Deficiency in Obese Thai Children
Official Title  ICMJE Thiamin Deficiency in Obese Thai Children
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Obesity
  • Child
  • Thiamine Deficiency
Intervention  ICMJE
  • 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

Study Arms  ICMJE
  • 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)
    Intervention: Drug: Thiamine 1
  • Non-thiamine
    no symptoms and signs of thiamine deficiency
    Intervention: Other: Non-thiamine
  • Experimental: Thiamine 2
    presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)
    Intervention: Drug: Thiamine 2
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2015)
124
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02464865
Other Study ID Numbers  ICMJE Si656/2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Narumon Densupsoontorn, MD Mahidol University
PRS Account Mahidol University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP