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Clinical Trial Summary

Study is an interventional clinical trial. children (aged 6-18 years) diagnosed with type 1 diabetes and celiac disease will be recruited conveniently from Endocrinology pediatric clinic at Prince Hamzah Hospital. Amman, Jordan. A sample of 45 diagnosed children, who will meet the inclusion criteria and will be agreed to participate will be centrally randomized to follow carbohydrate counting with GFD dietary intervention, carbohydrate counting with GFD and DASH dietary intervention, and control dietary intervention.


Clinical Trial Description

the main objective of this study to compare the effects of three diets: carbohydrate count with gluten-free diet, DASH and carbohydrate count with gluten-free diet, and gluten-free diet alone on glycemic control, growth rate, and the quality of life of 45 individual patients diagnosed with diabetes and celiac disease, who are receiving care in Prince Hamzah Hospital, and aged between 6-18 years, will be enrolled in this study. the duration of the follow-up will be up to ( 9 months); starting from the first interview and enrollment till reaching 9 months from the intervention. all the biochemical tests that are routinely measured will be recorded for each patients during the follow-up duration. these biochemical tests will be, mainly hemoglobin A1C, serum glucose, tissue-trans glutamines IgA( TTG IgA), vitamin D, calcium, phosphorus, and acute intermittent porphyria ( AIP) and will be recorded at baseline, after 6 months and at the end of the study (12 months). growth rate, and quality of life will be also assessed at based line, after 6 months and at the end of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05132725
Study type Interventional
Source University of Jordan
Contact marah AT al-majali, master
Phone +962797571009
Email marahmajali93@gmail.com
Status Recruiting
Phase N/A
Start date November 15, 2021
Completion date November 11, 2022

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