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Thiamin Deficiency in Obese Thai Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Obesity Child Thiamine Deficiency Drug: Thiamine 1 Other: Non-thiamine Drug: Thiamine 2 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Thiamin Deficiency in Obese Thai Children
Actual Study Start Date : August 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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


Non-thiamine
no symptoms and signs of thiamine deficiency
Other: Non-thiamine
no symptoms and signs of thiamine deficiency

Experimental: Thiamine 2
presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)
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





Primary Outcome Measures :
  1. abnormal thiamin pyrophosphate effect [ Time Frame: 7 days ]
    Thiamin pyrophosphate effect will be measured by a blood test


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464865


Locations
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Thailand
Faculty of Medicine Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Narumon Densupsoontorn, MD Mahidol University
Publications of Results:
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02464865    
Other Study ID Numbers: Si656/2014
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Keywords provided by Mahidol University:
thiamine deficiency
obese children
Thai
Additional relevant MeSH terms:
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Thiamine Deficiency
Beriberi
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs