Vitamin D-deficientVIDIRNCT01779908
Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance
A study testing Vitamin D in people with Vitamin D-deficient and Insulin-resistant, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in 130 Caucasian and vitamin D-deficient men and women aged 25 years and over. Participants will have abdominal obesity and at least one factor associated with insulin resistance. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Vitamin D-deficient, Insulin-resistant
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jun 2020
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasian men and women
- ≥25 yrs
- vitamin D deficiency [serum 25(OH)D concentration ≤55 nM]
- Abdominal obesity (waist circumference >=102 cm for men and >=88 cm for women) AND at least one factor associated with insulin resistance: (1) fasting serum triglycerides >=1.7 mmol/L or treated dyslipidemia; (2) prediabetes or untreated type 2 diabetes (HbA1c >=5.6% or fasting glucose >=5.6 mmol/L or 2h glucose post OGTT >=7.8 mmol/L); (3) first degree relative with type 2 diabetes; (4) history of gestational diabetes.
Who cannot join
- Type 2 diabetes under drug therapy
- HbA1c >7%
- BMI >40 kg/m2
- pregnancy or breast-feeding;
- medication influencing vitamin D or glucose metabolism in the last 3 mo
- regular consumption of supplements containing >400 IU/d of vitamin D3 over the last 2 mo;
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- renal insufficiency (creatinine clearance <60 ml/min);
- cirrhosis,
- intestinal malabsorption (bypass surgery, celiac disease, etc);
- osteoporosis;
- history of nephrolithiasis;
- hypercalcemia (>2.6 mM);
- hypercalciuria (>0.6 fasting urine Ca/creatinine ratio);
- >5% change in weight in the last 3 mo;
- diseases affecting glucose metabolism (e.g. hyperthyroidism);
- pacemaker (for bioimpedance only);
- inability to provide informed consent and complete questionnaires due to physical or mental problems.
Trial locations and contacts
1 site in 1 country.
Canada1 site
CHU de Québec, Laval University Research Center
Québec, Quebec, G1V 4G2
About this study
Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in 130 Caucasian and vitamin D-deficient men and women aged 25 years and over. Participants will have abdominal obesity and at least one factor associated with insulin resistance. Participants will be randomized by sex, BMI and age. The primary aim is to compare the effect of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin sensitivity (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp). Secondary aims are to evaluate the effects of vitamin D3 vs. placebo on other indices of glucose metabolism, the lipid profile, blood pressure and anthropometric measurements. Questionnaires on physical activity and sunlight exposure, and a food frequency questionnaire will be administered at 0 and 6 mo to adjust for confounding factors. At 0 and 6 mo, changes in serum 25(OH)D will be correlated with changes in blood markers associated with insulin sensitivity [hs-CRP, inflammatory cytokines (IL-6 and TNF-alpha), adiponectin, leptin, total and undercarboxylated osteocalcin].
This research project intends to test 2 major hypotheses: (1) that vitamin D deficiency plays a causal role in the pathogenesis of insulin resistance in humans; and (2) that vitamin D increases insulin sensitivity.
Read the detailed description
Part 1: Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in 130 Caucasian and vitamin D-deficient [serum 25(OH)D ≤55 nM] men and women aged 25 years and over with a BMI ≤40 kg/m2. Participants will have abdominal obesity (increased waist circumference of at least 102 cm for men and 88 cm for women) and at least one factor associated with insulin resistance, namely: (1) serum triglyceride levels of at least 1.7 mmol/L or treated dyslipidemia; (2) prediabetes or untreated type 2 diabetes (HbA1c >=5.6% or fasting glucose >=5.6 mmol/L or glucose 2h post OGTT >=7.8 mmol/L); (3) first degree relative with type 2 diabetes; (4) history of gestational diabetes. Participants will be randomized according to sex, BMI (<30 kg/m2 vs. 30 kg/m2 and over) and age (< or >=50 years old). The primary aim is to compare the effect of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin sensitivity (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp). Secondary aims are to evaluate the effects of vitamin D3 vs. placebo on other indices of glucose metabolism (fasting glucose, 2-h plasma glucose post OGTT, HbA1c, insulin sensitivity index (HOMA-IS using fasting glucose and insulin), insulin secretion index (HOMA-B using fasting glucose and C-peptide), insulinogenic index [(C-peptide at 30 min post OGTT - C-peptide at 0 min)/(glucose at 30 min post OGTT - glucose at 0 min)] and disposition index (insulinogenic index x M-value)), the lipid profile, blood pressure and anthropometric measurements (weight, waist and hip circumference, bioimpedance analysis). Questionnaires on physical activity and sunlight exposure, and a food frequency questionnaire will be administered at 0 and 6 mo to adjust for confounding factors. At 0 and 6 mo, biochemical markers associated with insulin sensitivity will be measured (point 2).
Part 2: Mechanistic studies comparing, before and after vitamin D3 supplementation, changes in serum 25(OH)D with changes in blood markers associated with insulin sensitivity [hs-CRP, inflammatory cytokines (IL-6 and TNF-alpha), adiponectin, leptin, total and undercarboxylated osteocalcin].
- Conditions
- Vitamin D-deficient, Insulin-resistant
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D supplementation, Insulin resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation | Experimental | 5000 IU of vitamin D3 for 6 months Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Placebo pill for 6 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral insulin sensitivity assessed by the euglycemic-hyperinsulinemic clamp between placebo and vitamin D groups
M-value
Measured: 0 and 6 months
Change in peripheral insulin sensitivity assessed by the euglycemic-hyperinsulinemic clamp between placebo and vitamin D groups
M/I ratio
Measured: 0 and 6 months
Secondary outcomes (15)
Change in insulin sensitivity indice assessed by fasting- and oral glucose tolerance test between placebo and vitamin D groups
HOMA2%S
Measured: 0 and 6 months
Change in insulin sensitivity indice assessed by fasting- and oral glucose tolerance test between placebo and vitamin D groups
Matsuda index
Measured: 0 and 6 months
Change in insulin secretion indice between placebo and vitamin D groups
area under the curve for C-peptide
Measured: 0 and 6 months
Change in insulin secretion indice between placebo and vitamin D groups
HOMA2-B
Measured: 0 and 6 months
Change in insulin secretion indice between placebo and vitamin D groups
insulinogenic index
Measured: 0 and 6 months
Change in B-cell function between placebo and vitamin D groups
Disposition index
Measured: 0 and 6 months
Change in metabolic markers between placebo and vitamin D groups
HbA1c
Measured: 0 and 6 months
Change in metabolic markers between placebo and vitamin D groups
Fasting glucose
Measured: 0 and 6 months
Change in metabolic markers between placebo and vitamin D groups
2h glucose post-OGTT
Measured: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
Weight
Measured: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
BMI
Measured: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
waist circumference
Measured: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
hip circumference
Measured: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
fat mass by bioimpedance analysis
Measured: 0 and 6 months
Change in blood pressure between placebo and vitamin D groups
Systolic and diastolic blood pressure
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion2 Jun 2017
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D-deficientStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association, Laval University, Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Claudia Gagnon, CHU de Quebec-Universite Laval
- Investigators
- Claudia Gagnon, Dr., Principal investigator, CHU de Québec Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779908
- Sponsor's protocol ID
- CDA grant no OG-3-12-3681-CG
- Other IDs
- B12-12-1095
- Acronym
- VIDIR
- Status last verified
- Jul 2020
- First submitted
- 24 Jan 2013
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance
- ClinicalTrials.gov ID
- NCT01779908
- Acronym / sponsor ID
- VIDIR / CDA grant no OG-3-12-3681-CG
- Conditions
- Vitamin D-deficient, Insulin-resistant
- Keywords
- Vitamin D supplementation, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association, Laval University, Fonds de la Recherche en Santé du Québec
- Study start
- Jan 2013
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 30 Jan 2013 (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.
Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in 130 Caucasian and vitamin D-deficient men and women aged 25 years and over. Participants will have abdominal obesity and at least one factor associated with insulin resistance. Participants will be randomized by sex, BMI and age. The primary aim is to compare the effect of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin sensitivity (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp). Secondary aims are to evaluate the effects of vitamin D3 vs. placebo on other indices of glucose metabolism, the lipid profile, blood pressure and anthropometric measurements. Questionnaires on physical activity and sunlight exposure, and a food frequency questionnaire will be administered at 0 and 6 mo to adjust for confounding factors. At 0 and 6 mo, changes in serum 25(OH)D will be correlated with changes in blood markers associated with insulin sensitivity [hs-CRP, inflammatory cytokines (IL-6 and TNF-alpha), adiponectin, leptin, total and undercarboxylated osteocalcin].
This research project intends to test 2 major hypotheses: (1) that vitamin D deficiency plays a causal role in the pathogenesis of insulin resistance in humans; and (2) that vitamin D increases insulin sensitivity.
Detailed description
Part 1: Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in 130 Caucasian and vitamin D-deficient [serum 25(OH)D ≤55 nM] men and women aged 25 years and over with a BMI ≤40 kg/m2. Participants will have abdominal obesity (increased waist circumference of at least 102 cm for men and 88 cm for women) and at least one factor associated with insulin resistance, namely: (1) serum triglyceride levels of at least 1.7 mmol/L or treated dyslipidemia; (2) prediabetes or untreated type 2 diabetes (HbA1c >=5.6% or fasting glucose >=5.6 mmol/L or glucose 2h post OGTT >=7.8 mmol/L); (3) first degree relative with type 2 diabetes; (4) history of gestational diabetes. Participants will be randomized according to sex, BMI (<30 kg/m2 vs. 30 kg/m2 and over) and age (< or >=50 years old). The primary aim is to compare the effect of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin sensitivity (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp). Secondary aims are to evaluate the effects of vitamin D3 vs. placebo on other indices of glucose metabolism (fasting glucose, 2-h plasma glucose post OGTT, HbA1c, insulin sensitivity index (HOMA-IS using fasting glucose and insulin), insulin secretion index (HOMA-B using fasting glucose and C-peptide), insulinogenic index [(C-peptide at 30 min post OGTT - C-peptide at 0 min)/(glucose at 30 min post OGTT - glucose at 0 min)] and disposition index (insulinogenic index x M-value)), the lipid profile, blood pressure and anthropometric measurements (weight, waist and hip circumference, bioimpedance analysis). Questionnaires on physical activity and sunlight exposure, and a food frequency questionnaire will be administered at 0 and 6 mo to adjust for confounding factors. At 0 and 6 mo, biochemical markers associated with insulin sensitivity will be measured (point 2).
Part 2: Mechanistic studies comparing, before and after vitamin D3 supplementation, changes in serum 25(OH)D with changes in blood markers associated with insulin sensitivity [hs-CRP, inflammatory cytokines (IL-6 and TNF-alpha), adiponectin, leptin, total and undercarboxylated osteocalcin].
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation | Experimental | Dietary Supplement: Vitamin D5000 IU of vitamin D3 for 6 months |
| Placebo | Placebo comparator | Other: PlaceboPlacebo pill for 6 months |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasian men and women
- ≥25 yrs
- vitamin D deficiency [serum 25(OH)D concentration ≤55 nM]
- Abdominal obesity (waist circumference >=102 cm for men and >=88 cm for women) AND at least one factor associated with insulin resistance: (1) fasting serum triglycerides >=1.7 mmol/L or treated dyslipidemia; (2) prediabetes or untreated type 2 diabetes (HbA1c >=5.6% or fasting glucose >=5.6 mmol/L or 2h glucose post OGTT >=7.8 mmol/L); (3) first degree relative with type 2 diabetes; (4) history of gestational diabetes.
Key exclusion criteria (17 listed)
- Type 2 diabetes under drug therapy
- HbA1c >7%
- BMI >40 kg/m2
- pregnancy or breast-feeding;
- medication influencing vitamin D or glucose metabolism in the last 3 mo
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 |
|---|---|---|
| Vitamin D | Dietary supplement | Vitamin D supplementation |
| Placebo | Other | Placebo |
Primary outcome
Change in peripheral insulin sensitivity assessed by the euglycemic-hyperinsulinemic clamp between placebo and vitamin D groups
Time frame: 0 and 6 months
M-value
Change in peripheral insulin sensitivity assessed by the euglycemic-hyperinsulinemic clamp between placebo and vitamin D groups
Time frame: 0 and 6 months
M/I ratio
15 secondary outcomes
Change in insulin sensitivity indice assessed by fasting- and oral glucose tolerance test between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in insulin sensitivity indice assessed by fasting- and oral glucose tolerance test between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in insulin secretion indice between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in insulin secretion indice between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in insulin secretion indice between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in B-cell function between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in metabolic markers between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in metabolic markers between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in metabolic markers between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in anthropometry between placebo and vitamin D groups
Time frame: 0 and 6 months
Change in blood pressure between placebo and vitamin D groups
Time frame: 0 and 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 24 Jul 2020.
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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.
Claudia Gagnon, Dr. principal investigator
CHU de Québec Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D-deficient and Insulin-resistant, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 17 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 24 Jul 2020. 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 Canada. 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 in peripheral insulin sensitivity assessed by the euglycemic-hyperinsulinemic clamp between placebo and vitamin D groups (time frame: 0 and 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?
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 24 Jul 2020.