- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01991054
The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency (VDD)
A Prospective, Double Blind, Randomized, Phase 4, Clinical Trial of The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Afula, 이스라엘, 1834111
- Haemek medical center, endocrone clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: vitamin D3 supplementation
The study group participants will receive vitamin D3 supplementation (120,000 I.U per month)for 6 months
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다른 이름들:
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위약 비교기: placebo group
placebo group, 15 ml per month for 6 months
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Hba1c (%) in study groups
기간: 2 years
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We assume that the treatment with vitamin D will improve diabetes control, as assessed by Hba1c .
The expected reduction in Hba1c levels will be 0.5%.
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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혈청 크레아티닌
기간: 2 년
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2 년
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혈압
기간: 2 년
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2 년
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Lipid profile
기간: 2 years
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Total cholesterol, LDL cholesterol , HDL cholesterol, non HDL cholesterol, Triglycerides
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2 years
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C-reactive protein
기간: 2 years
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2 years
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Body Weight
기간: 2 years
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2 years
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serum calcium
기간: 2 years
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2 years
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serum phosphore
기간: 2 years
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2 years
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serum PTH
기간: 2 years
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2 years
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serum albumin
기간: 2 years
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: avraham ishay, M.D, Haemek Medical Center
간행물 및 유용한 링크
일반 간행물
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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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- Mithal A, Wahl DA, Bonjour JP, Burckhardt P, Dawson-Hughes B, Eisman JA, El-Hajj Fuleihan G, Josse RG, Lips P, Morales-Torres J; IOF Committee of Scientific Advisors (CSA) Nutrition Working Group. Global vitamin D status and determinants of hypovitaminosis D. Osteoporos Int. 2009 Nov;20(11):1807-20. doi: 10.1007/s00198-009-0954-6. Epub 2009 Jun 19. Erratum In: Osteoporos Int. 2009 Nov;20(11):1821.
- Maalouf NM. The noncalciotropic actions of vitamin D: recent clinical developments. Curr Opin Nephrol Hypertens. 2008 Jul;17(4):408-15. doi: 10.1097/MNH.0b013e3283040c99.
- 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.
- Peelen E, Knippenberg S, Muris AH, Thewissen M, Smolders J, Tervaert JW, Hupperts R, Damoiseaux J. Effects of vitamin D on the peripheral adaptive immune system: a review. Autoimmun Rev. 2011 Oct;10(12):733-43. doi: 10.1016/j.autrev.2011.05.002. Epub 2011 May 18.
- Girgis CM, Clifton-Bligh RJ, Hamrick MW, Holick MF, Gunton JE. The roles of vitamin D in skeletal muscle: form, function, and metabolism. Endocr Rev. 2013 Feb;34(1):33-83. doi: 10.1210/er.2012-1012. Epub 2012 Nov 20.
- Wang L, Song Y, Manson JE, Pilz S, Marz W, Michaelsson K, Lundqvist A, Jassal SK, Barrett-Connor E, Zhang C, Eaton CB, May HT, Anderson JL, Sesso HD. Circulating 25-hydroxy-vitamin D and risk of cardiovascular disease: a meta-analysis of prospective studies. Circ Cardiovasc Qual Outcomes. 2012 Nov;5(6):819-29. doi: 10.1161/CIRCOUTCOMES.112.967604. Epub 2012 Nov 13.
- Binkley N, Ramamurthy R, Krueger D. Low vitamin D status: definition, prevalence, consequences, and correction. Endocrinol Metab Clin North Am. 2010 Jun;39(2):287-301, table of contents. doi: 10.1016/j.ecl.2010.02.008.
- Takiishi T, Gysemans C, Bouillon R, Mathieu C. Vitamin D and diabetes. Rheum Dis Clin North Am. 2012 Feb;38(1):179-206. doi: 10.1016/j.rdc.2012.03.015. Epub 2012 Apr 12.
- Cade C, Norman AW. Vitamin D3 improves impaired glucose tolerance and insulin secretion in the vitamin D-deficient rat in vivo. Endocrinology. 1986 Jul;119(1):84-90. doi: 10.1210/endo-119-1-84.
- Norman AW, Frankel JB, Heldt AM, Grodsky GM. Vitamin D deficiency inhibits pancreatic secretion of insulin. Science. 1980 Aug 15;209(4458):823-5. doi: 10.1126/science.6250216.
- Norman AW. Minireview: vitamin D receptor: new assignments for an already busy receptor. Endocrinology. 2006 Dec;147(12):5542-8. doi: 10.1210/en.2006-0946. Epub 2006 Aug 31.
- 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.
- Maestro B, Molero S, Bajo S, Davila N, Calle C. Transcriptional activation of the human insulin receptor gene by 1,25-dihydroxyvitamin D(3). Cell Biochem Funct. 2002 Sep;20(3):227-32. doi: 10.1002/cbf.951.
- 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.
- Maestro B, Campion J, Davila N, Calle C. Stimulation by 1,25-dihydroxyvitamin D3 of insulin receptor expression and insulin responsiveness for glucose transport in U-937 human promonocytic cells. Endocr J. 2000 Aug;47(4):383-91. doi: 10.1507/endocrj.47.383.
- 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.
- Muscogiuri G, Sorice GP, Ajjan R, Mezza T, Pilz S, Prioletta A, Scragg R, Volpe SL, Witham MD, Giaccari A. Can vitamin D deficiency cause diabetes and cardiovascular diseases? Present evidence and future perspectives. Nutr Metab Cardiovasc Dis. 2012 Feb;22(2):81-7. doi: 10.1016/j.numecd.2011.11.001. Epub 2012 Jan 21.
- 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.
- 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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- Borissova AM, Tankova T, Kirilov G, Dakovska L, Kovacheva R. The effect of vitamin D3 on insulin secretion and peripheral insulin sensitivity in type 2 diabetic patients. Int J Clin Pract. 2003 May;57(4):258-61.
- Major GC, Alarie F, Dore J, Phouttama S, Tremblay A. Supplementation with calcium + vitamin D enhances the beneficial effect of weight loss on plasma lipid and lipoprotein concentrations. Am J Clin Nutr. 2007 Jan;85(1):54-9. doi: 10.1093/ajcn/85.1.54.
- Grimnes G, Joakimsen R, Figenschau Y, Torjesen PA, Almas B, Jorde R. The effect of high-dose vitamin D on bone mineral density and bone turnover markers in postmenopausal women with low bone mass--a randomized controlled 1-year trial. Osteoporos Int. 2012 Jan;23(1):201-11. doi: 10.1007/s00198-011-1752-5. Epub 2011 Sep 10.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HGA1C vs D
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
비타민 D3에 대한 임상 시험
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Hospital Clinic of Barcelona알려지지 않은
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Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, Denmark완전한
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Haukeland University HospitalNorwegian Foundation for Health and Rehabilitation; Foundation to Promote Research into...완전한
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Haukeland University HospitalNorwegian Foundation for Health and Rehabilitation; Foundation to Promote Research into...완전한