Protocol summary
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Study aim
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Effect of vitamin D on pancreatic function and controlling of type 1 diabetes mellitus
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Design
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Clinical trial without control group; the sample size includes all of the eligibility criteria that 30-sample are predictable, phase 2 clinical trial.
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Settings and conduct
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This clinical trial study was performed will be selected by an inhomogeneous method in patients with type 1 diabetes mellitus referring to Amirkola Children's Hospital Endocrinology Clinic.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 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 0.8 milligram per deciliter
Exclusion criteria: not modify vitamin D after a course of vitamin D deficiency treatment.
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Intervention groups
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Type 1 diabetes mellitus children with a vitamin D level below 30 nanogram per mililiter will be treated with 50000 IU Pearl vitamin D for 9 months. The patients' C-peptide, 25OH (D), HbA1C and total daily insulin dose will be compared at the beginning and end of the study.
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Main outcome variables
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C-peptide; 25OH (D); HbA1C; Total daily insulin dose
General information
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Reason for update
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Acronym
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(Vitamin D (VD), Type 1 diabetes mellitus (T1DM
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IRCT registration information
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IRCT registration number:
IRCT20180228038900N2
Registration date:
2018-07-30, 1397/05/08
Registration timing:
retrospective
Last update:
2018-09-09, 1397/06/18
Update count:
2
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Registration date
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2018-07-30, 1397/05/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2016-09-22, 1395/07/01
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Expected recruitment end date
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2017-11-01, 1396/08/10
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Actual recruitment start date
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2016-09-22, 1395/07/01
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Actual recruitment end date
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2017-11-01, 1396/08/10
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Trial completion date
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empty
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Scientific title
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Effect of vitamin D on pancreatic function and controlling of type 1 diabetes mellitus
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Public title
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Effect of vitamin D on pancreas and controlling of T1DM
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
Not modify vitamin D after a course of vitamin D deficiency treatment
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Age
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No age limit
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
Actual sample size reached:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2016-11-09, 1395/08/19
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Ethics committee reference number
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IR.MUBABOL.REC.1395.48
Health conditions studied
1
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Description of health condition studied
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Type 1 diabetes mellitus
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ICD-10 code
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E10
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ICD-10 code description
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Type 1 diabetes mellitus
Primary outcomes
1
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Description
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C-peptide
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Timepoint
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At the beginning of the study (before intervention) and end of study (9 months after starting treatment)
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Method of measurement
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Blood serum level
2
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Description
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Hemoglobin A1C
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Timepoint
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At the beginning of the study (before intervention) and end of study (9 months after starting treatment)
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Method of measurement
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Blood serum level
3
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Description
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Total daily dose of Insuline
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Timepoint
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At the beginning of the study (before intervention) and every 3 months until end of study (9 months after starting treatment)
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Method of measurement
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Question of the parents of patient children (recorded in questionnaire)
4
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Description
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Vitamin D
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Timepoint
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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
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Method of measurement
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Blood serum level
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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When the data will become available and for how long
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To whom data/document is available
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Public access
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Under which criteria data/document could be used
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...
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From where data/document is obtainable
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Dr Morteza Alijanpour
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What processes are involved for a request to access data/document
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Email as soon as possible.
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Comments
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