ObesityPhase 4NCT02464865
Thiamin Deficiency in Obese Thai Children
A Phase 4 study testing Thiamine 1, Non-thiamine and Thiamine 2 in people with Obesity and Child, run by Mahidol University at 1 site in Thailand.
Trial summary
This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Child, Thiamine Deficiency
- What is being tested?
- Thiamine 1, Non-thiamine and Thiamine 2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2015to Aug 2018
- Phase
- Phase 4
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- obese : weight for height > median + 3 standard deviations
- simple obesity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.
Read the 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.
- Conditions
- Obesity, Child, Thiamine Deficiency
- Being tested
- Thiamine 1, Non-thiamine, Thiamine 2
- Keywords
- thiamine deficiency, obese children, Thai
- Medical subject headings
- Obesity, Thiamine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiamine 1Drug
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-thiamineOther
no symptoms and signs of thiamine deficiency
Thiamine 2Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Thiamine 1 | Experimental | 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) Receives: Drug: Thiamine 1 |
| Non-thiamine | Other | no symptoms and signs of thiamine deficiency Receives: Other: Non-thiamine |
| Thiamine 2 | Experimental | presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet) Receives: Drug: Thiamine 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
abnormal thiamin pyrophosphate effect
Thiamin pyrophosphate effect will be measured by a blood test
Measured: 7 days
Secondary outcomes (1)
consumption of thiaminase-containing foods and thiamin antagonist-containing foods
Food diary and food frequency questionaire will be required to evaluate food consumption
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narumon Densupsoontorn, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464865
- Sponsor's protocol ID
- Si656/2014
- Status last verified
- Sep 2018
- First submitted
- 18 May 2015
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23945419
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiamin Deficiency in Obese Thai Children
- ClinicalTrials.gov ID
- NCT02464865
- Acronym / sponsor ID
- Si656/2014
- Conditions
- Obesity, Child, Thiamine Deficiency
- Keywords
- thiamine deficiency, obese children, Thai
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 8 Jun 2015 (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.
This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thiamine 1 | Experimental | Drug: Thiamine 1presence 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) |
| Non-thiamine | Other | Other: Non-thiamineno symptoms and signs of thiamine deficiency |
| Thiamine 2 | Experimental | Drug: Thiamine 2presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet) |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- obese : weight for height > median + 3 standard deviations
- simple obesity
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thiamine 1If 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 | Drug | Thiamine 1 |
| Non-thiamineno symptoms and signs of thiamine deficiency | Other | Non-thiamine |
| Thiamine 2If 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 | Drug | Thiamine 2 |
Primary outcome
abnormal thiamin pyrophosphate effect
Time frame: 7 days
Thiamin pyrophosphate effect will be measured by a blood test
1 secondary outcome
consumption of thiaminase-containing foods and thiamin antagonist-containing foods
Time frame: 7 days
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 2 Oct 2018.
- Results publication: PubMed 23945419Densupsoontorn 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.
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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.
Narumon Densupsoontorn, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thiamine 1, Non-thiamine and Thiamine 2 in people with Obesity and Child, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 6 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 2 Oct 2018. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
abnormal thiamin pyrophosphate effect (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02464865, which also lists 1 linked publication.
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 2 Oct 2018.