Deficiency, Vitamin DNCT03478475
Vitamin D Supplementation and and Glycemic Indexes
A study testing cholecalciferol (Euro-Pharm International, Canada) in people with Deficiency, Vitamin D and Insulin Resistance, run by Université d'Auvergne.
Trial summary
Age affect insulin sensitivity and the metabolism, and vitamin D status was shown to have a correlation with markers of insulin resistance. That's why, we aimed in our trial to study the effect of vitamin D supplementation on glycemic markers and index of insulin resistance. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deficiency, Vitamin D, Insulin Resistance
- 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
- 115 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2015to 19 Sep 2015
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- -Deficiency in vitamin D and having no medical history of type 2 diabetes mellitus
Who cannot join
- patients with a history of type-2-diabetes, congestive heart failure, liver failure, renal failure, cancer, or taking oral hypoglycemic drugs or statin therapy, or patients having metabolic bone disease.
About this study
Official title: Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: a Randomized Controlled Trial
Age affect insulin sensitivity and the metabolism, and vitamin D status was shown to have a correlation with markers of insulin resistance. That's why, we aimed in our trial to study the effect of vitamin D supplementation on glycemic markers and index of insulin resistance.
Read the detailed description
A low serum 25-hydroxyvitamin D [(25(OH) D)] concentration was shown to correlate with higher fasting blood glucose (FBG) and insulin levels. Since age affect insulin sensitivity and the metabolism, we aimed in this randomized controlled trial to investigate the effect of vitamin D supplementation on glucose homeostasis and index of insulin resistance in elderly subjects living in Beirut, Lebanon.
Participants (n= 115) deficient in vitamin D were randomly divided into two groups, a group receiving 30,000 IU cholecalciferol/week for a period of 6 months, and a placebo group. The index of insulin resistance HOMA (homeostasis model assessment) was the primary outcome. Glucose homeostasis and metabolic markers were also measured at start of treatment and at 6 months.
- Conditions
- Deficiency, Vitamin D, Insulin Resistance
- Being tested
- cholecalciferol (Euro-Pharm International, Canada), Placebo
- Keywords
- Vitamin D, HOMA-IR, Glucose, HbA1C, insulin resistance
- Medical subject headings
- Vitamin D Deficiency, Insulin Resistance
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
PlaceboOther
Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) Receives: Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada) |
| Placebo group | Placebo comparator | The placebo group received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA-IR
The HOMA-IR formula was as following: HOMA-IR = [insulin (mU/L) × glucose (mg/dL)]/22.5 where IR is the mutual of percentage sensitivity with a normal value of 1.0.
Measured: 6 months
25 (OH)D
Vitamin D
Measured: 6 months
Secondary outcomes (7)
BMI
Body mass Index
Measured: 6 months
FBG
Fasting blood glucose
Measured: 6 months
FBI
Fasting Blood inslin
Measured: 6 months
HbA1C
Glycated hemoglobin
Measured: 6 months
Total cholesterol
Total cholesterol
Measured: 6 months
LDL cholesterol
LDL cholesterol
Measured: 6 months
HDL cholesterol
HDL cholesterol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start2 Jul 2015
- Primary completion19 Sep 2015
- Study completion19 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deficiency, Vitamin DStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a randomized, controlled, double blind study. Participants were randomized into 2 groups; the vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) and the placebo group who also received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving. The treatment was led for a period of 6 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université d'Auvergne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478475
- Sponsor's protocol ID
- SSCC012
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Hajj C, Chardigny JM, Boirie Y, Yammine K, Helou M, Walrand S. Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: A Randomized Controlled Trial. J Nutr Health Aging. 2018;22(9):1128-1132. doi: 10.1007/s12603-018-1083-8.
PubMed 30379314
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03478475
- Acronym / sponsor ID
- SSCC012
- Conditions
- Deficiency, Vitamin D, Insulin Resistance
- Keywords
- Vitamin D, HOMA-IR, Glucose, HbA1C, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Université d'AuvergneUniversity, hospital or other
- Study start
- 2 Jul 2015 (actual)
- Primary completion
- 19 Sep 2015 (actual)
- Study completion
- 19 Sep 2015 (actual)
- First posted
- 27 Mar 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.
Age affect insulin sensitivity and the metabolism, and vitamin D status was shown to have a correlation with markers of insulin resistance. That's why, we aimed in our trial to study the effect of vitamin D supplementation on glycemic markers and index of insulin resistance.
Detailed description
A low serum 25-hydroxyvitamin D [(25(OH) D)] concentration was shown to correlate with higher fasting blood glucose (FBG) and insulin levels. Since age affect insulin sensitivity and the metabolism, we aimed in this randomized controlled trial to investigate the effect of vitamin D supplementation on glucose homeostasis and index of insulin resistance in elderly subjects living in Beirut, Lebanon.
Participants (n= 115) deficient in vitamin D were randomly divided into two groups, a group receiving 30,000 IU cholecalciferol/week for a period of 6 months, and a placebo group. The index of insulin resistance HOMA (homeostasis model assessment) was the primary outcome. Glucose homeostasis and metabolic markers were also measured at start of treatment and at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This was a randomized, controlled, double blind study. Participants were randomized into 2 groups; the vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) and the placebo group who also received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving. The treatment was led for a period of 6 months.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) |
| Placebo group | Placebo comparator | Other: PlaceboThe placebo group received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- -Deficiency in vitamin D and having no medical history of type 2 diabetes mellitus
Key exclusion criteria (1 listed)
- patients with a history of type-2-diabetes, congestive heart failure, liver failure, renal failure, cancer, or taking oral hypoglycemic drugs or statin therapy, or patients having metabolic bone 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) | Dietary supplement | Vitamin D group |
| PlaceboPlacebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%) | Other | Placebo group |
Primary outcome
HOMA-IR
Time frame: 6 months
The HOMA-IR formula was as following: HOMA-IR = [insulin (mU/L) × glucose (mg/dL)]/22.5 where IR is the mutual of percentage sensitivity with a normal value of 1.0.
25 (OH)D
Time frame: 6 months
Vitamin D
7 secondary outcomes
BMI
Time frame: 6 months
FBG
Time frame: 6 months
FBI
Time frame: 6 months
HbA1C
Time frame: 6 months
Total cholesterol
Time frame: 6 months
LDL cholesterol
Time frame: 6 months
HDL cholesterol
Time frame: 6 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 29 Mar 2018.
- Derived from this study: PubMed 30379314El Hajj C, Chardigny JM, Boirie Y, Yammine K, Helou M, Walrand S. Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: A Randomized Controlled Trial. J Nutr Health Aging. 2018;22(9):1128-1132. doi: 10.1007/s12603-018-1083-8.
- Individual participant dataSharing planned: No
Related trials for Deficiency, Vitamin D
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol (Euro-Pharm International, Canada) in people with Deficiency, Vitamin D and Insulin Resistance, run by Université d'Auvergne.
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 1 inclusion and 1 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
HOMA-IR (time frame: 6 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?
On the ClinicalTrials.gov record for NCT03478475, which also lists 1 linked publication.
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 29 Mar 2018.