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Completed

NCT Number: NCT02464865

Thiamin Deficiency in Obese Thai Children

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

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Key information

Conditions

Obesity Avitaminosis Body Weight Child Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Thiamine Deficiency Vitamin B Deficiency

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thiamine 1

Drug

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

Other

no symptoms and signs of thiamine deficiency

Thiamine 2

Drug

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 outcomes

  1. abnormal thiamin pyrophosphate effect

    Time frame: 7 days

    Thiamin pyrophosphate effect will be measured by a blood test

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 8, 2015
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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