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Trial record 7 of 32 for:    Interleukin-10

Effect of Vitamin D Supplementation on Fasting Glucose and Interleukin-10 (IL-10) in Arab Women With Impaired Fasting Glucose

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ClinicalTrials.gov Identifier: NCT00877123
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : November 10, 2011
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services

Tracking Information
First Submitted Date  ICMJE April 6, 2009
First Posted Date  ICMJE April 7, 2009
Last Update Posted Date November 10, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2009)
  • fasting glucose [ Time Frame: 4 months ]
  • interleukin-10 level [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
  • fasting glucose [ Time Frame: 4 months ]
  • interleukin-6 level [ Time Frame: 4 months ]
Change History Complete list of historical versions of study NCT00877123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
hs-CRP level [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin D Supplementation on Fasting Glucose and Interleukin-10 (IL-10) in Arab Women With Impaired Fasting Glucose
Official Title  ICMJE Prospective, Randomized, Double Blind Placebo Controled Clinical Trial to Assess the Effect of Vitamin D Supplementation on Fasting Glucose and IL-10 in Arab Women With Impaired Fasting Glucose.
Brief Summary Obesity, and its metabolic consequences - impaired fasting glucose (IFG) and diabetes, is highly prevalent among Arab women in Israel and the Middle East. Since life style modification is difficult to achieve in this population it is important to assess whether other modifiable risk factors can be detected. There is evidence that the homeostasis of vitamin D has a significant role in the eventual development of diabetes. Previous cross sectional studies have shown that low 25 (OH) vitamin D levels are related to glucose intolerance, diabetes, insulin resistance and metabolic syndrome. The study hypothesis is that 25(OH) vitamin D deficiency is highly prevalent among Arab women with IFG and that vitamin D supplementation may improve IFG and by that reduce the risk for future overt diabetes. Additionally, obesity is associated with a low-grade inflammation of white adipose tissue (WAT) resulting from chronic activation of the innate immune system. In obesity, there is an increased production and secretion of a wide range of inflammatory molecules including interleukin-10 (IL-10), which may have systemic effects on WAT and other organs. To that end the investigators will assess the influence of vitamin D supplementation on IL-10 and hs-CRP.
Detailed Description

Eligible women will be invited by their primary care physician to participate in the study. After signing an informed consent women will be randomized to receive oral vitamin D 100,000 IU or similar placebo once a month for three consecutive months. Pertinent clinical and demographic date will be documented and relevant laboratory test will be performed by the primary care team. One month after the third dose the same data and tests will be retrieved on each woman. Compliance with the study protocol will be enhanced and confirmed by a research assistant.

Objectives:

To assess the relationship between IFG and 25(OH) vitamin D levels in overweight Arab women.

To assess whether vitamin D supplementation significantly improves IFG. To assess whether vitamin D supplementation significantly modifies IL-10 and hs-CRP.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: Oral vitamin D 100,000 IU
    Oral vitamin D 100,000 IU once a month for three consecutive months.
  • Drug: Placebo
    similar placebo once a month for three consecutive months
Study Arms  ICMJE
  • Experimental: Vitamin D
    Intervention arm: Oral vitamin D 100,000 IU once a month for three consecutive months.
    Intervention: Drug: Oral vitamin D 100,000 IU
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2011)
74
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2009)
80
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Arab women, age 40-65
  • No significant handicap or disabilities in ADL
  • BMI > 25 kg/m2
  • IFG of 100-125 mg/dl

Exclusion Criteria:

  • Diabetes Mellitus
  • Other medical conditions that may have an effect on IFG (cancer, chronic renal failure, inflammatory diseases etc)
  • History of vascular disease
  • Regular use of medications that may affect IFG (steroids, HRT, diuretics etc)
  • Hypercalcemia (albumin corrected Ca >10.3 mg/dl)
  • Inability to sign an informed consent due to mental or psychiatric ailment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00877123
Other Study ID Numbers  ICMJE K-09-43-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uzi Milman, Clalit Health Services
Study Sponsor  ICMJE Clalit Health Services
Collaborators  ICMJE Rambam Health Care Campus
Investigators  ICMJE
Principal Investigator: Naim Shehadeh, MD Faculty of Medicine, Technion, Haifa,
Principal Investigator: Uzi Milman, MD Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District and the Department of Family Medicine, Faculty of Medicine, Technion- Israel Institute of Technology, HAIFA, ISRAEL.
Principal Investigator: Sophia Ish-Shalom, MD Faculty of Medicine, Technion, Haifa,
Principal Investigator: Gila Rosen, PhD Rambam Health Care Campus
Principal Investigator: Mira Barak,, PhD Clalit Health Services, Haifa and Western Galilee District
PRS Account Clalit Health Services
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP