Thiamin Deficiency in Obese Thai Children

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

Tracking Information

• First Submitted Date: May 18, 2015
• First Posted Date: June 8, 2015
• Last Update Posted Date: October 2, 2018
• Actual Study Start Date: August 2015
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Thiamin Deficiency in Obese Thai Children
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening

Condition

• Obesity
• Child
• Thiamine Deficiency

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

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 3, 2015): 124
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2018
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 15 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT02464865
• Other Study ID Numbers: Si656/2014
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mahidol University
• Study Sponsor: Mahidol University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Narumon Densupsoontorn, MD; Mahidol University

• PRS Account: Mahidol University
• Verification Date: September 2018