NCT00877123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 10, 2011

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

April 6, 2009

Last Update Submit

November 9, 2011

Conditions

Obesity

Keywords

fasting glucoseobesityarab womeninterleukindiabetesimpaired fasting glucose (IFG)

Outcome Measures

Primary Outcomes (2)

  • fasting glucose

    4 months

  • interleukin-10 level

    4 months

Secondary Outcomes (1)

  • hs-CRP level

    4 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

Intervention arm: Oral vitamin D 100,000 IU once a month for three consecutive months.

Drug: Oral vitamin D 100,000 IU

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Oral vitamin D 100,000 IUDRUG

Oral vitamin D 100,000 IU once a month for three consecutive months.

Vitamin D
PlaceboDRUG

similar placebo once a month for three consecutive months

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services, Haifa and Western Galilee District

Haifa, Israel

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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.

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 10, 2011

Record last verified: 2009-10

Locations

IL(1)