ObesityPhase 4NCT00877123
Effect of Vitamin D Supplementation on Fasting Glucose and Interleukin-10 (IL-10) in Arab Women With Impaired Fasting Glucose
A Phase 4 study testing Oral vitamin D 100,000 IU in people with Obesity, run by Clalit Health Services at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Oral vitamin D 100,000 IU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arab women, age 40-65
- No significant handicap or disabilities in ADL
- BMI > 25 kg/m2
- IFG of 100-125 mg/dl
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Oral vitamin D 100,000 IU, Placebo
- Keywords
- fasting glucose, obesity, arab women, interleukin, diabetes, impaired fasting glucose (IFG)
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral vitamin D 100,000 IUDrug
Oral vitamin D 100,000 IU once a month for three consecutive months.
PlaceboDrug
similar placebo once a month for three consecutive months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Intervention arm: Oral vitamin D 100,000 IU once a month for three consecutive months. Receives: Drug: Oral vitamin D 100,000 IU |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting glucose
Measured: 4 months
interleukin-10 level
Measured: 4 months
Secondary outcomes (1)
hs-CRP level
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Principal investigator, Uzi Milman, Clalit Health Services
- Investigators
- Naim Shehadeh, MD, Principal investigator, Faculty of Medicine, Technion, Haifa,Uzi Milman, MD, Principal investigator, 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.Sophia Ish-Shalom, MD, Principal investigator, Faculty of Medicine, Technion, Haifa,Gila Rosen, PhD, Principal investigator, Rambam Health Care CampusMira Barak,, PhD, Principal investigator, Clalit Health Services, Haifa and Western Galilee District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877123
- Sponsor's protocol ID
- K-09-43-CTIL
- Status last verified
- Oct 2009
- First submitted
- 6 Apr 2009
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00877123
- Acronym / sponsor ID
- K-09-43-CTIL
- Conditions
- Obesity
- Keywords
- fasting glucose, obesity, arab women, interleukin, diabetes, impaired fasting glucose (IFG)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- Rambam Health Care Campus
- Study start
- Jun 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Oral vitamin D 100,000 IUIntervention arm: Oral vitamin D 100,000 IU once a month for three consecutive months. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Arab women, age 40-65
- No significant handicap or disabilities in ADL
- BMI > 25 kg/m2
- IFG of 100-125 mg/dl
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral vitamin D 100,000 IUOral vitamin D 100,000 IU once a month for three consecutive months. | Drug | Vitamin D |
| Placebosimilar placebo once a month for three consecutive months | Drug | Placebo |
Primary outcome
fasting glucose
Time frame: 4 months
interleukin-10 level
Time frame: 4 months
1 secondary outcome
hs-CRP level
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naim Shehadeh, MD principal investigator
Faculty of Medicine, Technion, Haifa,
Uzi Milman, MD principal investigator
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.
Sophia Ish-Shalom, MD principal investigator
Faculty of Medicine, Technion, Haifa,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral vitamin D 100,000 IU in people with Obesity, run by Clalit Health Services at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting glucose (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2011.