Thiamin (Vitamin B1) Levels in Eating Disorder Adolescent Patients

May 24, 2020 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center

Evaluating the B1 Status in Eating Disorder Female Adolescent Patients

Vitamin B1 (Thiamine) is a water soluble essential nutrient; it is synthesized by a variety of plants and microorganisms. Since animals usually cannot synthesis it, humans must be supplied with exogenous vitamin B1 in the diet. The human storage of thiamine is small- about 30mg, an intake of 1-2 mg a day is needed to maintain this pool. Deficiency might occur when the vitamin is depleted from the diet in a short period. Vitamin B1 has a role in energy metabolism and main biosynthetic pathways. Low thiamine causes illnesses in the central and peripheral nervous systems as well as affecting the heart and gastrointestinal systems.

Deficiency may occur from malnutrition of different mechanisms such as alcoholism, lack in diet and recently secondary to anti-obesity surgery and few case reports described eating disorders as the reason for developing deficiency causing neuropathy, (1,2) and encephalopathy (3,4,5).

One of the presentations of thiamine deficiency is peripheral neuropathy mimicking Guillain-Barre syndrome, and administering the lacking vitamin improves the symptoms.

One study examined the prevalence of vitamin B1 deficiency in adult anorexia nervosa patients (6) by measurement of the activation of the enzyme erythrocyte transketolase following addition of thiamin pyrophosphate and comparing them to control of blood donors. This study found significant lower levels of vitamin B1 in the anorectic patient compared to the controls.

Rational of the study:

The investigators assume that these few cases described of overt neurologic impairment due to vitamin B1 deficiency because of distorted eating are just the "tip of the iceberg" and more eating disorders patients lack thiamine, that may have neuropsychiatric effect on the illness and identifying and treating the shortage may improve the symptoms of the disorder and maybe even the distorted thoughts that are fundamental in eating disorders.

Study Overview

Status

Completed

Conditions

Detailed Description

Methods:

In Assaf Harofe medical center over 50 adolescents (mainly girls) aged 10-18 years are treated annually for eating disorders by a multidisciplinary team. Their nutritional and medical condition is assessed also by blood analysis routinely. The investigators are planning to check thiamine status in eating disorders female patients in different stages of treatment, comparing them with age and sex matched controls that do not have eating disorders problems. The control group will be recruited from patient treated in the outpatient day hospital and have blood tested anyhow that don't suffer from eating, metabolic, nutritional or gastrointestinal disorders.

The researchers will look for correlation between different types of eating disorders, nutritional state, treatment progress and levels of vitamin B1.

Thiamin will be determined in whole blood using High-Performance Liquid Chromatography (HPLC) that is superior to the previous method as described above, determining thiamin diphosphate; the physiologically active form of vitamin B1 accurately.

Sample size: A previous study on thiamine concentration in 50 healthy French volunteers found a standard deviation (SD) of 15 nmol/l (7). 17 patients in each group were required in order to detect a 15 nmol/l difference in mean thiamine levels with a power of 80% and Alfa of 0.05. In order to overcome a possibly higher SD and to allow for subgroup analysis , we decided to recruit 30 patients for each group.

Study Type

Observational

Enrollment (Actual)

69

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

      • Zrifin, Israel, 70300
        • Pediatric devision Assaf harofeh MC

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

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

adolescent girls with eating disordes aged 12-18

Description

Inclusion Criteria:

  • Adolescent girls aged 12-18

Exclusion Criteria:

  • Girls suffering from metabolic
  • Nutritional or gastrointestinal disorders

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

Cohorts and Interventions

Group / Cohort
B1 blood levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
establishing B1 levels
Time Frame: one year
one year

Collaborators and Investigators

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

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

March 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 6, 2013

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 24, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 214/12

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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