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

This study has been completed.
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT00877123
First received: April 6, 2009
Last updated: November 9, 2011
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
 Drug: Oral vitamin D 100,000 IU
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • fasting glucose [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • interleukin-10 level [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hs-CRP level [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: June 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Intervention arm: Oral vitamin D 100,000 IU once a month for three consecutive months.
 Drug: Oral vitamin D 100,000 IU
Oral vitamin D 100,000 IU once a month for three consecutive months.
Placebo Comparator: Placebo Drug: Placebo
similar placebo once a month for three consecutive months
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877123

Locations
Israel
Clalit Health Services, Haifa and Western Galilee District
Haifa, Israel
Sponsors and Collaborators
Clalit Health Services
Rambam Health Care Campus
Investigators
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
  More Information

No publications provided

Responsible Party: Uzi Milman, Director, 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., Clalit Health Services
ClinicalTrials.gov Identifier: NCT00877123     History of Changes
Other Study ID Numbers: K-09-43-CTIL
Study First Received: April 6, 2009
Last Updated: November 9, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
fasting glucose
obesity
arab women
 interleukin
diabetes
impaired fasting glucose (IFG)

Additional relevant MeSH terms:
Obesity
Prediabetic State
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013