Thiamin Deficiency in Obese Thai Children

September 28, 2018 updated by: Mahidol University
This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
abnormal thiamin pyrophosphate effect
Time Frame: 7 days
Thiamin pyrophosphate effect will be measured by a blood test
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Narumon Densupsoontorn, MD, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si656/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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