A Phase 4 interventional study of Thiamine 1 and Non-thiamine in Obesity, Child and Thiamine Deficiency, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 7 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Mahidol University · Phase 4, Interventional, and Screening
Among 12 studies in Obesity by Mahidol University — 6 open to participants now, 6 under way, none of them phase 3. Obesity · Mahidol University.
Among the 12 studies in Obesity by Mahidol University, this one is one of 2 that started in 2015, is the only one in phase 4, and was the 2nd registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 124 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →6 of the 12 studies in Obesity by Mahidol University are open now, in 1 country. Each count lists the studies.
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 7 Years to 15 Years · all sexes · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2015.
Median enrollment 75 across the 8 interventional studies, 115 across the 4 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Obesity by Mahidol University, from their registry updates:
This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Thiamine 1
no symptoms and signs of thiamine deficiency
Other: Non-thiamine
presence of mild symptoms and signs of thiamine deficiency; peripheral neuropathy alone (paraesthesia of hands and feet)
Drug: Thiamine 2
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
no symptoms and signs of thiamine deficiency
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
abnormal thiamin pyrophosphate effect
Thiamin pyrophosphate effect will be measured by a blood test
Time frame: 7 days
consumption of thiaminase-containing foods and thiamin antagonist-containing foods
Food diary and food frequency questionaire will be required to evaluate food consumption
Time frame: 7 days
Ran from Aug 2015 to primary completion in Jul 2018, 35 months.
Of 190 non-industry phase 4 interventional studies under Obesity, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's 35 months is close to that.
Counting every sponsor, half of 210 studies reached it within 31 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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