DiabetesPhase 3NCT01019642
Vitamin D, C-reactive Protein and Insulin Resistance
A Phase 3 study testing cholecalciferol in people with Diabetes and Low-intensity Chronic Inflammation, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
Trial summary
Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Diabetes, Low-intensity Chronic Inflammation, Insulin Resistance
- What is being tested?
- cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2008to Oct 2008
- Phase
- Phase 3
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus w/ < 10 yrs of diagnosis
- Postmenopausal
- Overweight or obesity (BMI >=25)
- Treated with metformin
Who cannot join
- BMI >=40
- Liver or kidney disease
- Other important chronic disease: i.e. cancer, autoimmune.
- Receiving insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin D Supplementation on C-reactive Protein and Insulin Resistance in Postmenopausal Women With Type 2 Diabetes Mellitus
Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus.
The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM).
The trial was conducted from March to October 2008 at the Hospital of the Mexican Social Security in Cuernavaca, Mexico.
Read the detailed description
Methods. Randomized, double blind, placebo-controlled clinical trial. We selected 104 postmenopausal women, ages 45 to 65, with uncomplicated T2DM and BMI ≥25. Women with history of kidney or liver disease, BMI>40, autoimmune disease or cancer were not included in the study.
Participants were randomly assigned to receive either a capsule containing 4,000 IU of vitamin D3 (cholecalciferol, n=52) or placebo (n=52), once a day during 6 months.
Outcome variables were serum CRP, measured with a high-sensitivity assay (nephelometry), and HOMA-IR. Serum vitamin D (25-OH-D) was measured by HPLC. Outcome variables were measured at baseline, and 3 and 6 months thereafter. All participants received diet and physical activity counseling, and visited the clinic for medical check-up once a month.
Baseline Results. Mean age was 56.8 ± 5.1 y. Baseline BMI was 30.7 ± 3.9. Median CRP concentration was 5.0 mg/L (Interquartile range: 1.0, 8.5). HOMA index at baseline was 7.13 ± 3.8. Serum 25-OH-D concentration at baseline was 54.5 ± 15.7 nmol/L (~22 ng/mL). Almost 94% of patients had baseline serum 25-OH-D levels <80 nmol/L, and 25% were below 40 nmol/L. No one had levels <20 nmol/L. There were no statistical differences on important variables by treatment group at the onset of study.
- Being tested
- cholecalciferol, placebo
- Keywords
- vitamin D, diabetes, C-reactive protein, insulin resistance
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDrug
4,000 IU per day during 6 months. Capsule form.
placeboDrug
no active principles given.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Cholecalciferol, 4,000 IU/d for 6 months Receives: Drug: cholecalciferol |
| Placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-.
Measured: 3 and 6 months
Insulin resistance, measured by HOMA-IR index
Measured: 3 and 6 months
Secondary outcomes (1)
Serum 25-OH-vitamin D3 levels
Measured: 3 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 posted25 Nov 2009 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social, Ellison Medical / International Nutrition Foundation, Tufts University
- Investigators
- Mario E Flores, MD, MSc, Principal investigator, Instituto Nacional de Salud Publica, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019642
- Sponsor's protocol ID
- 120-6371
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Flores M. A role of vitamin D in low-intensity chronic inflammation and insulin resistance in type 2 diabetes mellitus? Nutr Res Rev. 2005 Dec;18(2):175-82. doi: 10.1079/NRR2005104.
PubMed 19079903Munoz-Aguirre P, Flores M, Macias N, Quezada AD, Denova-Gutierrez E, Salmeron J. The effect of vitamin D supplementation on serum lipids in postmenopausal women with diabetes: A randomized controlled trial. Clin Nutr. 2015 Oct;34(5):799-804. doi: 10.1016/j.clnu.2014.10.002. Epub 2014 Oct 13.
PubMed 25453396
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on C-reactive Protein and Insulin Resistance in Postmenopausal Women With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01019642
- Acronym / sponsor ID
- 120-6371
- Keywords
- vitamin D, diabetes, C-reactive protein, insulin resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social, Ellison Medical / International Nutrition Foundation, Tufts University
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 25 Nov 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.
Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus.
The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM).
The trial was conducted from March to October 2008 at the Hospital of the Mexican Social Security in Cuernavaca, Mexico.
Detailed description
Methods. Randomized, double blind, placebo-controlled clinical trial. We selected 104 postmenopausal women, ages 45 to 65, with uncomplicated T2DM and BMI ≥25. Women with history of kidney or liver disease, BMI>40, autoimmune disease or cancer were not included in the study.
Participants were randomly assigned to receive either a capsule containing 4,000 IU of vitamin D3 (cholecalciferol, n=52) or placebo (n=52), once a day during 6 months.
Outcome variables were serum CRP, measured with a high-sensitivity assay (nephelometry), and HOMA-IR. Serum vitamin D (25-OH-D) was measured by HPLC. Outcome variables were measured at baseline, and 3 and 6 months thereafter. All participants received diet and physical activity counseling, and visited the clinic for medical check-up once a month.
Baseline Results. Mean age was 56.8 ± 5.1 y. Baseline BMI was 30.7 ± 3.9. Median CRP concentration was 5.0 mg/L (Interquartile range: 1.0, 8.5). HOMA index at baseline was 7.13 ± 3.8. Serum 25-OH-D concentration at baseline was 54.5 ± 15.7 nmol/L (~22 ng/mL). Almost 94% of patients had baseline serum 25-OH-D levels <80 nmol/L, and 25% were below 40 nmol/L. No one had levels <20 nmol/L. There were no statistical differences on important variables by treatment group at the onset of study.
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: cholecalciferolCholecalciferol, 4,000 IU/d for 6 months |
| Placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus w/ < 10 yrs of diagnosis
- Postmenopausal
- Overweight or obesity (BMI >=25)
- Treated with metformin
Key exclusion criteria (4 listed)
- BMI >=40
- Liver or kidney disease
- Other important chronic disease: i.e. cancer, autoimmune.
- Receiving insulin
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 |
|---|---|---|
| cholecalciferol4,000 IU per day during 6 months. Capsule form. | Drug | Vitamin D |
| placebono active principles given. | Drug | Placebo |
Primary outcome
Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-.
Time frame: 3 and 6 months
Insulin resistance, measured by HOMA-IR index
Time frame: 3 and 6 months
1 secondary outcome
Serum 25-OH-vitamin D3 levels
Time frame: 3 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 25 Nov 2009.
- Background: PubMed 19079903Flores M. A role of vitamin D in low-intensity chronic inflammation and insulin resistance in type 2 diabetes mellitus? Nutr Res Rev. 2005 Dec;18(2):175-82. doi: 10.1079/NRR2005104.
- Derived from this study: PubMed 25453396Munoz-Aguirre P, Flores M, Macias N, Quezada AD, Denova-Gutierrez E, Salmeron J. The effect of vitamin D supplementation on serum lipids in postmenopausal women with diabetes: A randomized controlled trial. Clin Nutr. 2015 Oct;34(5):799-804. doi: 10.1016/j.clnu.2014.10.002. Epub 2014 Oct 13.
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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.
Mario E Flores, MD, MSc principal investigator
Instituto Nacional de Salud Publica, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cholecalciferol in people with Diabetes and Low-intensity Chronic Inflammation, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
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 4 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 25 Nov 2009. 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-. (time frame: 3 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?
On the ClinicalTrials.gov record for NCT01019642, which also lists 2 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 25 Nov 2009.