Thiamin Deficiency in Obese Thai Children

NCT ID: NCT02464865

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity Child Thiamine Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Thiamine 1

Intervention Type 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

no symptoms and signs of thiamine deficiency

Group Type OTHER

Non-thiamine

Intervention Type OTHER

no symptoms and signs of thiamine deficiency

Thiamine 2

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

Group Type EXPERIMENTAL

Thiamine 2

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Non-thiamine

no symptoms and signs of thiamine deficiency

Intervention Type OTHER

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Narumon Densupsoontorn, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of Medicine Siriraj Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 23945419 (View on PubMed)

Other Identifiers

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Si656/2014

Identifier Type: -

Identifier Source: org_study_id

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