Vitamin D DeficiencyNCT03782805
Effect of Vitamin D Supplementation on Inflammatory Markers
A study testing cholecalciferol (Euro-Pharm International, Canada) in people with Vitamin D Deficiency and Type2 Diabetes, run by Université d'Auvergne at 1 site in Lebanon.
Trial summary
Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in some inflammatory markers, especially with patients with type 2 diabetes. The aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in patients having type 2 diabetes. Read more about this study
- Who is it for?
- Ages 60 to 72 years
- Conditions the study is for
- Vitamin D Deficiency, Type2 Diabetes
- What is being tested?
- cholecalciferol (Euro-Pharm International, Canada)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteLebanon
- Study dates
- 9 May 2018to 9 Jul 2018
- Phase
- Interventional
- 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 60 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects deficient in vitamin D
- Subjects having type 2 diabetes
- Non-obese subjects
Who cannot join
- Subjects having hyperparathyroidism
- Subjects suffering from hepatic disease / kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes
Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in some inflammatory markers, especially with patients with type 2 diabetes. The aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in patients having type 2 diabetes.
Read the detailed description
Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled, double blind study is to examine the effect of vitamin D supplementation on some inflammatory markers in older Lebanese patients having type 2 diabetes.
- Conditions
- Vitamin D Deficiency, Type2 Diabetes
- Being tested
- cholecalciferol (Euro-Pharm International, Canada), Placebo tablet
- Keywords
- vitamin D, type 2 diabetes, inflammation
- Medical subject headings
- Vitamin D Deficiency, Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol (Euro-Pharm International, Canada)Dietary supplement
The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months
Placebo tabletDietary supplement
The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Group receiving a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) to be taken 3 times a week for a period of six months. Receives: Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada) |
| Placebo group | Placebo comparator | Group receiving a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months Receives: Dietary Supplement: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline fasting blood glucose (FBG) at 6 months
FASTING BLOOD GLUCOSE
Measured: baseline and after 6 months of intervention
Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months
Homeostatic Model Assessment of Insulin Resistance
Measured: baseline and after 6 months of intervention
Change from Baseline C-reactive protein (CRP) at 6 months
C-reactive protein
Measured: baseline and after 6 months of intervention
Change from Baseline Interleukin-6 (IL-6) at 6 months
Interleukin-6
Measured: baseline and after 6 months of intervention
Change from Baseline TNF-alpha at 6 months
TNF-alpha
Measured: baseline and after 6 months of intervention
Secondary outcomes (5)
Change from Baseline weight at 6 months
weight change
Measured: baseline and after 6 months of intervention
Change from Baseline Body Mass Index (BMI) at 6 months
Body mass index
Measured: baseline and after 6 months of intervention
Change from Baseline waist circumference at 6 months
Waist circumference change
Measured: baseline and after 6 months of intervention
Change from Baseline Percentage of fat at 6 months
Percentage of fat
Measured: baseline and after 6 months of intervention
Change from Baseline Parathyroid hormone (PTH) at 6 months
Parathyroid hormone
Measured: baseline and after 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start9 May 2018
- Primary completion7 Jun 2018
- Study completion9 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this randomized, controlled, double blind study, participants were randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université d'Auvergne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia E Hajj, PhD, Study director, Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782805
- Sponsor's protocol ID
- 222222
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan will be shared upon request
Publications
Yu Y, Tian L, Xiao Y, Huang G, Zhang M. Effect of Vitamin D Supplementation on Some Inflammatory Biomarkers in Type 2 Diabetes Mellitus Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab. 2018;73(1):62-73. doi: 10.1159/000490358. Epub 2018 Jun 26.
PubMed 29945132Safarpour P, Vafa MR, Amiri F, Janani L, Noorbakhsh M, Rajabpour Nikoo E, Sadeghi H. A double blind randomized clinical trial to investigate the effect of vitamin D supplementation on metabolic and hepato-renal markers in type 2 diabetes and obesity. Med J Islam Repub Iran. 2018 Apr 28;32:34. doi: 10.14196/mjiri.32.34. eCollection 2018.
PubMed 30159285El Hajj C, Walrand S, Helou M, Yammine K. Effect of Vitamin D Supplementation on Inflammatory Markers in Non-Obese Lebanese Patients with Type 2 Diabetes: A Randomized Controlled Trial. Nutrients. 2020 Jul 9;12(7):2033. doi: 10.3390/nu12072033.
PubMed 32659891
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03782805
- Acronym / sponsor ID
- 222222
- Conditions
- Vitamin D Deficiency, Type2 Diabetes
- Keywords
- vitamin D, type 2 diabetes, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Université d'AuvergneUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 20 Dec 2018 (actual)
- 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.
Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in some inflammatory markers, especially with patients with type 2 diabetes. The aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in patients having type 2 diabetes.
Detailed description
Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled, double blind study is to examine the effect of vitamin D supplementation on some inflammatory markers in older Lebanese patients having type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In this randomized, controlled, double blind study, participants were randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)Group receiving a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) to be taken 3 times a week for a period of six months. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo tabletGroup receiving a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months |
Who may qualify
- Ages
- 60 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects deficient in vitamin D
- Subjects having type 2 diabetes
- Non-obese subjects
Key exclusion criteria (2 listed)
- Subjects having hyperparathyroidism
- Subjects suffering from hepatic disease / kidney disease
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 |
|---|---|---|
| cholecalciferol (Euro-Pharm International, Canada)The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months | Dietary supplement | treatment group |
| Placebo tabletThe participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months | Dietary supplement | Placebo group |
Primary outcome
Change from Baseline fasting blood glucose (FBG) at 6 months
Time frame: baseline and after 6 months of intervention
FASTING BLOOD GLUCOSE
Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months
Time frame: baseline and after 6 months of intervention
Homeostatic Model Assessment of Insulin Resistance
Change from Baseline C-reactive protein (CRP) at 6 months
Time frame: baseline and after 6 months of intervention
C-reactive protein
Change from Baseline Interleukin-6 (IL-6) at 6 months
Time frame: baseline and after 6 months of intervention
Interleukin-6
Change from Baseline TNF-alpha at 6 months
Time frame: baseline and after 6 months of intervention
TNF-alpha
5 secondary outcomes
Change from Baseline weight at 6 months
Time frame: baseline and after 6 months of intervention
Change from Baseline Body Mass Index (BMI) at 6 months
Time frame: baseline and after 6 months of intervention
Change from Baseline waist circumference at 6 months
Time frame: baseline and after 6 months of intervention
Change from Baseline Percentage of fat at 6 months
Time frame: baseline and after 6 months of intervention
Change from Baseline Parathyroid hormone (PTH) at 6 months
Time frame: baseline and after 6 months of intervention
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 21 Dec 2018.
- Background: PubMed 29945132Yu Y, Tian L, Xiao Y, Huang G, Zhang M. Effect of Vitamin D Supplementation on Some Inflammatory Biomarkers in Type 2 Diabetes Mellitus Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab. 2018;73(1):62-73. doi: 10.1159/000490358. Epub 2018 Jun 26.
- Background: PubMed 30159285Safarpour P, Vafa MR, Amiri F, Janani L, Noorbakhsh M, Rajabpour Nikoo E, Sadeghi H. A double blind randomized clinical trial to investigate the effect of vitamin D supplementation on metabolic and hepato-renal markers in type 2 diabetes and obesity. Med J Islam Repub Iran. 2018 Apr 28;32:34. doi: 10.14196/mjiri.32.34. eCollection 2018.
- Derived from this study: PubMed 32659891El Hajj C, Walrand S, Helou M, Yammine K. Effect of Vitamin D Supplementation on Inflammatory Markers in Non-Obese Lebanese Patients with Type 2 Diabetes: A Randomized Controlled Trial. Nutrients. 2020 Jul 9;12(7):2033. doi: 10.3390/nu12072033.
- Individual participant dataSharing planned: No. The plan will be shared upon request
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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.
Cynthia E Hajj, PhD study director
Dr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol (Euro-Pharm International, Canada) in people with Vitamin D Deficiency and Type2 Diabetes, run by Université d'Auvergne at 1 site in Lebanon.
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 3 inclusion and 2 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 21 Dec 2018. 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 Lebanon. 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.
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?
Change from Baseline fasting blood glucose (FBG) at 6 months (time frame: baseline and after 6 months of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03782805, which also lists 3 linked publications.
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 21 Dec 2018.