Eating DisordersNCT02164487
Thiamin (Vitamin B1) Levels in Eating Disorder Adolescent Patients
An observational study of Eating Disorders, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 19 years, women only
- Conditions the study is for
- Eating Disorders
- How many people
- 69 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2013to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: adolescent girls with eating disordes aged 12-18
Who may be able to join
- Adolescent girls aged 12-18
Who cannot join
- Girls suffering from metabolic
- Nutritional or gastrointestinal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Eating Disorders
- Keywords
- B1 adolescents Eating disorders Thaimine
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| B1 blood levels | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
establishing B1 levels
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164487
- Sponsor's protocol ID
- 214/12
- Status last verified
- May 2020
- First submitted
- 6 Jun 2013
- Last updated
- 27 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the B1 Status in Eating Disorder Female Adolescent Patients
- ClinicalTrials.gov ID
- NCT02164487
- Acronym / sponsor ID
- 214/12
- Conditions
- Eating Disorders
- Keywords
- B1 adolescents Eating disorders Thaimine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B1 blood levels | – | – |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- adolescent girls with eating disordes aged 12-18
Key inclusion criteria (1 listed)
- Adolescent girls aged 12-18
Key exclusion criteria (2 listed)
- Girls suffering from metabolic
- Nutritional or gastrointestinal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
establishing B1 levels
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
establishing B1 levels (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.