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IRCT20180228038900N2 IRCT 2018-07-30 Babol University of Medical Sciences Effect of vitamin D on pancreas and controlling of T1DM (Vitamin D (VD), Type 1 diabetes mellitus (T1DM Effect of vitamin D on pancreatic function and controlling of type 1 diabetes mellitus 2016-09-22 anticipated 40 Complete https://irct.ir/trial/32742 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: The patients' C-peptide (as a marker of β-cells function), HbA1C and total daily dose (TDD) insulin (as markers of T1DM controlling) and 25 (OH) D were compared at the beginning and end of the study. 2 Type 1 diabetes mellitus. Type 1 diabetes mellitus children who had been treated with long-acting insulin (glargine) and fast-acting insulin (aspart) based on the Basal Bolus Insulin Protocol (BBIP) in the last five years, with at least 6 months after the onset of their diabetes will be selected as the sample and their C-peptide levels will be tested, initially. The, those children who have basal C-peptide levels> 0.2 nmol/l will be tested for vitamin D (VD) levels. Those with 25(OH) D levels lower than 30 (ng/ml), which means decreased level of VD, will be included in the study. If their VD level be between 20 and 30 (ng/ml), indicating VD insufficiency, they will receive D-VITIN 50000U PEARL per week for up to 6 weeks, and if their VD level be lower than 20 (ng/ml), which indicates VD deficiency (15), they will receive D-VITIN 50000U PEARL for up to 8 weeks. Then, the children's VD levels will be re-tested and if it will be shown to be low, the weekly treatment with the same previous level will be continued until they have normal VD levels (more than 30 (ng/ml). If they will fail to reach a normal level of this vitamin after another six-to-eight-week period of D-VITIN PEARL, the patients will be excluded from the study. After correcting the patients' levels of VD, a single dose of VD will be administered for each month until the end of the study (9 months) and finally, their C-peptide, 25OH (D), and HbA1C levels will be checked again and their C-peptide, 25OH (D), HbA1C and TDD will be compared at the beginning and end of the study. Insulin Lantus (Glargine) was manufactured by SANOFI-Aventis Germany and Insulin Novorapid (aspart) was manufactured by NOVO NORDISK A/S, a Danish multinational pharmaceutical company. D-VITIN 50000U PEARL was manufactured by Zahravi Pharmaceutical Company in Iran. To check the above, we needed 3 cc of blood clots. C-peptide will be measured by the ELISA method using a Diasorin kit produced in Italy, VD will be measured by the ELISA method using the Ids kit made in England and HbA1C will be measured by an enzymatic method using a Pishtazteb kit made in Iran, and the results will be recorded.. Yes - There is a plan to make this available What will be shared: - When: - To whom: Public access Conditions: ... Where to obtain: Dr Morteza Alijanpour How to obtain: Email as soon as possible. Comments:
public Morteza Alihanpour Aghamaleki
No19
Babol Iran (Islamic Republic of) 4731741151 +98 11 3234 6963 m.alijanpour@mubabol.ac.ir Babol University of Medical Sciences scientific Morteza Aljanpour Aghamaleki
No 19
Babol Iran (Islamic Republic of) 4731741151 +98 11 3234 6963 m.alijanpour@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Children who have been diagnosed with type 1 diabetes mellitus in the last five years  and they referred to Endocrinology Clinic of Amirkola Children's Hospital C-peptid above 0.2 nanomol per liter Vitamin D level lower than 30 nano-gram per milliliter Calcium above 8.5 milligram per deciliter no limit no limit Both Not modify vitamin D after a course of vitamin D deficiency treatment E10 Type 1 diabetes mellitus Treatment - Drugs Type 1 diabetes mellitus children who had been treated with long-acting insulin (glargine) and fast-acting insulin (aspart) based on the Basal Bolus Insulin Protocol (BBIP) in the last five years, with at least 6 months after the onset of their diabetes will be selected as the sample and their C-peptide levels will be tested, initially. The, those children who have basal C-peptide levels> 0.2 nmol/l will be tested for vitamin D (VD) levels. Those with 25(OH) D levels lower than 30 (ng/ml), which means decreased level of VD, will be included in the study. If their VD level be between 20 and 30 (ng/ml), indicating VD insufficiency, they will receive D-VITIN 50000U PEARL per week for up to 6 weeks, and if their VD level be lower than 20 (ng/ml), which indicates VD deficiency (15), they will receive D-VITIN 50000U PEARL for up to 8 weeks. Then, the children's VD levels will be re-tested and if it will be shown to be low, the weekly treatment with the same previous level will be continued until they have normal VD levels (more than 30 (ng/ml). If they will fail to reach a normal level of this vitamin after another six-to-eight-week period of D-VITIN PEARL, the patients will be excluded from the study. After correcting the patients' levels of VD, a single dose of VD will be administered for each month until the end of the study (9 months) and finally, their C-peptide, 25OH (D), and HbA1C levels will be checked again and their C-peptide, 25OH (D), HbA1C and TDD will be compared at the beginning and end of the study. Insulin Lantus (Glargine) was manufactured by SANOFI-Aventis Germany and Insulin Novorapid (aspart) was manufactured by NOVO NORDISK A/S, a Danish multinational pharmaceutical company. D-VITIN 50000U PEARL was manufactured by Zahravi Pharmaceutical Company in Iran. To check the above, we needed 3 cc of blood clots. C-peptide will be measured by the ELISA method using a Diasorin kit produced in Italy, VD will be measured by the ELISA method using the Ids kit made in England and HbA1C will be measured by an enzymatic method using a Pishtazteb kit made in Iran, and the results will be recorded. C-peptide. Timepoint: At the beginning of the study (before intervention) and end of study (9 months after starting treatment). Method of measurement: Blood serum level. Hemoglobin A1C. Timepoint: At the beginning of the study (before intervention) and end of study (9 months after starting treatment). Method of measurement: Blood serum level. Total daily dose of Insuline. Timepoint: At the beginning of the study (before intervention) and every 3 months until end of study (9 months after starting treatment). Method of measurement: Question of the parents of patient children (recorded in questionnaire). Vitamin D. Timepoint: At the beginning of the study (before intervention) and based on vitamin D level, 6 or 8 weeks later and if modified, end of study. Method of measurement: Blood serum level. Babol University of Medical Sciences Approved 2016-11-09 Ethics committee of Babol University of Medical Sciences Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street Babol Mazandaran Iran (Islamic Republic of)