The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency
NCT ID: NCT01991054
Last Updated: 2018-02-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
45 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-12-31
Study Completion Date
2018-01-31
Brief Summary
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Vitamin D plays a key role in keeping normal mineral balance and maintaining bone health. There is accumulating evidence linking deficient vitamin D status with both type 1 and type 2 diabetes.
The purpose of this study is to evaluate the effect of high dose vitamin D supplementation (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin D deficient patients with non-optimally controlled type 2 diabetes mellitus.
The purpose of this study is to evaluate the effect of high dose vitamin D supplementation (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin D deficient patients with non-optimally controlled type 2 diabetes mellitus.
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Detailed Description
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This is a randomized, double blind, parallel group, clinical trial for 6 months duration.
The study group participants will receive vitamin D supplementation (120,000 IU per month) versus the placebo group for 6 months. glycemic control indexes will be measured in T2DM diagnosed study subjects.
Patient will be randomized 1:1 to one of two treatment groups. Vitamin D group vs placebo group.
Randomization kits will include either vitamin D or vitamin D placebo. Blood screens will be taken prior, after 3 months from randomization and after 6 months from randomization. Anthropometric measurements will be drawn as well, at the same time points.
Determination of sample size In order to find a 0.5 mean difference in HgA1C between the two treatment arms (standard deviation 1.2) a 184 sample size will be required to achieve 80% power, 5% alpha (two sided test).
ADMINISTRATIVE AND LEGAL OBLIGATIONS:
Individual patient's medical information obtained as result of this study is considered confidential and disclosure to third parties.
The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
Source and study documents will be locked under the supervision of the PI- principle investigator for 15 years.
Study documentations and storage The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
All persons authorized to make entries and/or correction on CRF will be included on the investigators team list delegation log.
Study printout and electronic CRF's, ICF's and other study documents will be stored in the at Haemek medical center under the supervision of the PI. All identifying details will be completely erased.
The investigator and staff are responsible for maintaining a comprehensive and centralized filing system of all study- related documentation, suitable for inspection at any time.
The study group participants will receive vitamin D supplementation (120,000 IU per month) versus the placebo group for 6 months. glycemic control indexes will be measured in T2DM diagnosed study subjects.
Patient will be randomized 1:1 to one of two treatment groups. Vitamin D group vs placebo group.
Randomization kits will include either vitamin D or vitamin D placebo. Blood screens will be taken prior, after 3 months from randomization and after 6 months from randomization. Anthropometric measurements will be drawn as well, at the same time points.
Determination of sample size In order to find a 0.5 mean difference in HgA1C between the two treatment arms (standard deviation 1.2) a 184 sample size will be required to achieve 80% power, 5% alpha (two sided test).
ADMINISTRATIVE AND LEGAL OBLIGATIONS:
Individual patient's medical information obtained as result of this study is considered confidential and disclosure to third parties.
The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
Source and study documents will be locked under the supervision of the PI- principle investigator for 15 years.
Study documentations and storage The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
All persons authorized to make entries and/or correction on CRF will be included on the investigators team list delegation log.
Study printout and electronic CRF's, ICF's and other study documents will be stored in the at Haemek medical center under the supervision of the PI. All identifying details will be completely erased.
The investigator and staff are responsible for maintaining a comprehensive and centralized filing system of all study- related documentation, suitable for inspection at any time.
Conditions
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Diabetes Mellitus
Vitamin D Deficiency
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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vitamin D3 supplementation
The study group participants will receive vitamin D3 supplementation (120,000 I.U per month)for 6 months
Group Type
EXPERIMENTAL
vitamin D3
Intervention Type
DIETARY_SUPPLEMENT
placebo group
placebo group, 15 ml per month for 6 months
Group Type
PLACEBO_COMPARATOR
vitamin D3
Intervention Type
DIETARY_SUPPLEMENT
Interventions
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vitamin D3
Intervention Type
DIETARY_SUPPLEMENT
Other Intervention Names
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Cholecalciferol
Eligibility Criteria
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Inclusion Criteria
* Written inform consent must be obtained from the patient before any assessment is performed.
* Male or female patient, 18 years or older.
* Diabetes mellitus patients.
* HgA1C levels on randomization above 7.5% in the last 6 months.
* Low 25(OH) vitamin D levels : under 50nmol/l
* Male or female patient, 18 years or older.
* Diabetes mellitus patients.
* HgA1C levels on randomization above 7.5% in the last 6 months.
* Low 25(OH) vitamin D levels : under 50nmol/l
Exclusion Criteria
* Patient who are unable consume food orally.
* Life expectancy under 7 month.
* Unable to sign inform consent.
* Patient unwilling or unable to comply with study procedure.
* Life expectancy under 7 month.
* Unable to sign inform consent.
* Patient unwilling or unable to comply with study procedure.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Sponsor Role
lead
Responsible Party
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avraham ishay
endocronologist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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avraham ishay, M.D
Role: PRINCIPAL_INVESTIGATOR
haemek medical center
Locations
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Haemek medical center, endocrone clinic
Afula, , Israel
Site Status
Countries
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Israel
References
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Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
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Toubi E, Shoenfeld Y. The role of vitamin D in regulating immune responses. Isr Med Assoc J. 2010 Mar;12(3):174-5. No abstract available.
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Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
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Maestro B, Davila N, Carranza MC, Calle C. Identification of a Vitamin D response element in the human insulin receptor gene promoter. J Steroid Biochem Mol Biol. 2003 Feb;84(2-3):223-30. doi: 10.1016/s0960-0760(03)00032-3.
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Dunlop TW, Vaisanen S, Frank C, Molnar F, Sinkkonen L, Carlberg C. The human peroxisome proliferator-activated receptor delta gene is a primary target of 1alpha,25-dihydroxyvitamin D3 and its nuclear receptor. J Mol Biol. 2005 Jun 3;349(2):248-60. doi: 10.1016/j.jmb.2005.03.060. Epub 2005 Apr 7.
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Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.
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Scragg R, Sowers M, Bell C; Third National Health and Nutrition Examination Survey. Serum 25-hydroxyvitamin D, diabetes, and ethnicity in the Third National Health and Nutrition Examination Survey. Diabetes Care. 2004 Dec;27(12):2813-8. doi: 10.2337/diacare.27.12.2813.
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Oosterwerff MM, Eekhoff EM, Heymans MW, Lips P, van Schoor NM. Serum 25-hydroxyvitamin D levels and the metabolic syndrome in older persons: a population-based study. Clin Endocrinol (Oxf). 2011 Nov;75(5):608-13. doi: 10.1111/j.1365-2265.2011.04110.x.
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Husemoen LL, Skaaby T, Thuesen BH, Jorgensen T, Fenger RV, Linneberg A. Serum 25(OH)D and incident type 2 diabetes: a cohort study. Eur J Clin Nutr. 2012 Dec;66(12):1309-14. doi: 10.1038/ejcn.2012.134. Epub 2012 Oct 3.
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Forouhi NG, Luan J, Cooper A, Boucher BJ, Wareham NJ. Baseline serum 25-hydroxy vitamin d is predictive of future glycemic status and insulin resistance: the Medical Research Council Ely Prospective Study 1990-2000. Diabetes. 2008 Oct;57(10):2619-25. doi: 10.2337/db08-0593. Epub 2008 Jun 30.
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Boucher BJ, Mannan N, Noonan K, Hales CN, Evans SJ. Glucose intolerance and impairment of insulin secretion in relation to vitamin D deficiency in east London Asians. Diabetologia. 1995 Oct;38(10):1239-45. doi: 10.1007/BF00422375.
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Orwoll E, Riddle M, Prince M. Effects of vitamin D on insulin and glucagon secretion in non-insulin-dependent diabetes mellitus. Am J Clin Nutr. 1994 May;59(5):1083-7. doi: 10.1093/ajcn/59.5.1083.
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Pittas AG, Harris SS, Stark PC, Dawson-Hughes B. The effects of calcium and vitamin D supplementation on blood glucose and markers of inflammation in nondiabetic adults. Diabetes Care. 2007 Apr;30(4):980-6. doi: 10.2337/dc06-1994. Epub 2007 Feb 2.
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Nagpal J, Pande JN, Bhartia A. A double-blind, randomized, placebo-controlled trial of the short-term effect of vitamin D3 supplementation on insulin sensitivity in apparently healthy, middle-aged, centrally obese men. Diabet Med. 2009 Jan;26(1):19-27. doi: 10.1111/j.1464-5491.2008.02636.x.
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George PS, Pearson ER, Witham MD. Effect of vitamin D supplementation on glycaemic control and insulin resistance: a systematic review and meta-analysis. Diabet Med. 2012 Aug;29(8):e142-50. doi: 10.1111/j.1464-5491.2012.03672.x.
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Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr. 2006 Jul;84(1):18-28. doi: 10.1093/ajcn/84.1.18.
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Aloia JF, Patel M, Dimaano R, Li-Ng M, Talwar SA, Mikhail M, Pollack S, Yeh JK. Vitamin D intake to attain a desired serum 25-hydroxyvitamin D concentration. Am J Clin Nutr. 2008 Jun;87(6):1952-8. doi: 10.1093/ajcn/87.6.1952.
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BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.hc-sc.gc.ca/fn-an/nutrition/vitamin/vita-d-eng.php
41\. "Vitamin D and Calcium: Updated Dietary Reference Intakes". Nutrition and Healthy Eating. Health Canada. Retrieved 2012-06-13.
http://www.fda.gov.
42\. U.S. Food and Drug Administration: Guidance for Industry: A Food labeling Guide.
Other Identifiers
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HGA1C vs D
Identifier Type: -
Identifier Source: org_study_id
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