Diabetes Mellitus, Type 2NCT03734445
Effect of Vitamin C, D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects
A study testing Vitamin Supplement in people with Diabetes Mellitus, Type 2, run by Universidad Autonoma del Estado de Mexico.
Trial summary
Type 2 Diabetes Mellitus According to the World Health Organization (WHO), there are more than 346 million individuals with diabetes, of which 90% are type 2. Global estimations for the year 2030 predict an epidemic increase that will reach 366 million. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vitamin Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2020to 26 Mar 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 25 and 55 years of age, as this is the age in which type 2 diabetes mellitus is more prevalent and there is less probability of encountering multiple diseases in the same subjects
- Both sexes
- Outpatients
- BMI ≥ 25
Who cannot join
- Without any other chronic disease (cancer, cardiovascular diseases, arthritis and Alzheimer's).
- Severe renal insufficiency.
- Nephrolithiasis or history of nephrolithiasis.
- Hyperoxaluria.
- Hemochromatosis.
- Hypercalcaemia.
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- Hypervitaminosis D.
- Using insulin.
- Be taking drugs such as desferrioxamine, iron, cyclosporine, indinavir (protease inhibitors), warfarin, thiazide diuretic, orlistat, ion exchange resins (e.g cholestyramine, laxatives (e.g. mineral oil, senna), vitamin d analogues (e.g. ergocalciferol, calcitriol, and topical calcipotriene), tetracycline antibiotics, quinolone antibiotics, penicillamine, biphosphonates, levothyroxine, eltrombopag.
- Patients with hypersensitivity to any of the active substance(s) or to any of the excipients.
- Hypersensitivity to the by-products including honey, conifers, poplars, Peru balsam, and salicylate.
- Intake of probiotics or supplemental vitamin or mineral (vitamin D, C, zinc or calcium) for 4 weeks before the beginning of the study.
- Smoking and alcohol consumption (> 40 gr/ day for men and 25 gr/ day for women.
- Pregnant or lactating.
- Whose parents or grandparents are/were immigrant or of native origin.
About this study
Official title: Effect of Vitamin C, Vitamin D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects in Mexico
Type 2 Diabetes Mellitus According to the World Health Organization (WHO), there are more than 346 million individuals with diabetes, of which 90% are type 2. Global estimations for the year 2030 predict an epidemic increase that will reach 366 million. According to the National Nutrition and Health Survey of 2006 (ENSANUT2005), there are 6.4 million type 2 diabetic subjects in Mexico.
According to the calculation of the sample size, the investigators will include 120 adults with type 2 diabetes mellitus selected from the outpatient preventive medicine offices of health centres in the State of Mexico who will divided in two groups: supplement and placebo (60 per group). After having been invited to participate and obtaining the informed consent, study subjects will be evaluated for dietary information, as well as biochemical biomarkers of metabolic control, anthropometric, immune and inflammatory markers, gut microbiota and oxidative stress, before beginning the trial, and after 12 and 24 weeks of supplementation. They will have a monthly follow-up visit for evaluation of adherence and adverse effects, as well as delivery of the supplement.
Read the detailed description
Subjects will be randomly allocated to a supplementation with 1000 mg vitamin C, 400 IU vitamin D and 10 mg of zinc or placebo group, during 24 weeks. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vitamin Supplement, Placebo
- Keywords
- Diabetes Mellitus type 2, Vitamin C, Vitamin D, Cinc
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin SupplementDietary supplement
Subjects will be randomly allocated to a supplementation of vitamin C 1000mg, vitamin D 400 IU and zinc 10 mg or an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding
PlaceboOther
Subjects will be randomly allocated to a supplementation of an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding
| Study group | Role | What they receive |
|---|---|---|
| Vitamin supplement | Experimental | Effervescent tablets containing Vitamin C, Vitamin D and zinc Receives: Dietary Supplement: Vitamin Supplement |
| Placebo | Placebo comparator | Effervescent tablets not containing Vitamin C, Vitamin D and zinc Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemia from baseline to 12 and 24 weeks
Measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL
Measured: Baseline, 12 and 24 weeks
Change in glycosilated Hemoglobin (Hb1Ac) from baseline to 12 and 24 weeks
Measured in plasma with a Selectra II automated equipment with Randox reactants, in percentage
Measured: Baseline, 12 and 24 weeks
Change in plasma insulin from baseline to 12 and 24 weeks
Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in uU/mL
Measured: Baseline, 12 and 24 weeks
Change in Homeostatic Model Assesment for Insulin Resistance (HOMA-IR) from baseline to 12 and 24 weeks
Calculated from: HOMA-IR = (insulin x glucose)/405
Measured: Baseline, 12 and 24 weeks
Secondary outcomes (7)
Change in plasma cytokines from baseline to 12 and 24 weeks
Tumor Necrosis Factor alfa (TNFα), Interferon gamma (IFN-γ), Interleukins 1 beta, 4, 6 and 10 (IL-1β, IL4, IL-6, IL10) \& transforming growth factor beta (TGF-β), measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL
Measured: Baseline, 12 and 24 weeks
Change in plasma adipokines from baseline to 12 and 24 weeks
Adiponectin, resistin and leptin, measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL
Measured: Baseline, 12 and 24 weeks
Change in additional plasma inflammatory markers from baseline to 12 and 24 weeks
Apolipoproteins A and B, C-reactive protein, vascular cell adhesion protein (V-CAM), intercellular adhesion molecule (I-CAM), complement proteins C-3 and C-4, measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL
Measured: Baseline, 12 and 24 weeks
Change in lipid profile from baseline to 12 and 24 weeks
Total cholesterol, HDL-, LDL-, Very Low Density Lipoprotein (VLDL)-cholesterol and triacylglycerides, measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL
Measured: Baseline, 12 and 24 weeks
Changes in markers of oxidative stress from baseline to 12 and 24 weeks
Malondialdehyde (QuantiChromTM), Thiobarbituric acid reactive substances (TBARS Assay Kit), carbonylated proteins (colorimetric), antioxidant capacity (QuantiChromTM Antioxidant Assay Kit), catalase (EnzyChromTM Catalase Assay Kit), superoxide dismutase (EnzyChromTM Superoxide Dismutase Assay Kit) and glutathion peroxidase (metaphosphoric acid SIGMA ALDRICH y EnzyChromTM GSH/GSSG Assay Kit, measured with various commercial kits, in U/μL
Measured: Baseline, 12 and 24 weeks
Changes in lymphocyte subpopulations from baseline to 12 and 24 weeks
Cluster of desgination 4, 8, 17 and 19 (CD4+, CD8+, CD17+ and CD19+), measured by flow cytometry (Becton Dickinson Facs AriaMR de 6 canales), in percentage
Measured: Baseline, 12 and 24 weeks
Changes in Intestinal microbiota patterns from baseline to 12 and 24 weeks
Analyzed with a Illumina sequencing equipment and Mothur y Stamp softwares, in percentage
Measured: Baseline, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start9 Jan 2020 (estimated)
- Primary completion9 Jan 2020 (estimated)
- Study completion26 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Subjects will be randomly allocated to two groups (vitamin supplement or placebo), with a duration of 24 weeks. Dietary and compliance monthly follow-up and baseline, 12 and 24-week measurements.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma del Estado de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roxana Valdés Ramos, Universidad Autonoma del Estado de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734445
- Sponsor's protocol ID
- 2018/11
- Status last verified
- Nov 2018
- First submitted
- 5 Jul 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin C, Vitamin D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects in Mexico
- ClinicalTrials.gov ID
- NCT03734445
- Acronym / sponsor ID
- 2018/11
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus type 2, Vitamin C, Vitamin D, Cinc
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad Autonoma del Estado de MexicoUniversity, hospital or other
- Study start
- 9 Jan 2020 (estimated)
- Primary completion
- 9 Jan 2020 (estimated)
- Study completion
- 26 Mar 2020 (estimated)
- First posted
- 8 Nov 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.
Type 2 Diabetes Mellitus According to the World Health Organization (WHO), there are more than 346 million individuals with diabetes, of which 90% are type 2. Global estimations for the year 2030 predict an epidemic increase that will reach 366 million. According to the National Nutrition and Health Survey of 2006 (ENSANUT2005), there are 6.4 million type 2 diabetic subjects in Mexico.
According to the calculation of the sample size, the investigators will include 120 adults with type 2 diabetes mellitus selected from the outpatient preventive medicine offices of health centres in the State of Mexico who will divided in two groups: supplement and placebo (60 per group). After having been invited to participate and obtaining the informed consent, study subjects will be evaluated for dietary information, as well as biochemical biomarkers of metabolic control, anthropometric, immune and inflammatory markers, gut microbiota and oxidative stress, before beginning the trial, and after 12 and 24 weeks of supplementation. They will have a monthly follow-up visit for evaluation of adherence and adverse effects, as well as delivery of the supplement.
Detailed description
Subjects will be randomly allocated to a supplementation with 1000 mg vitamin C, 400 IU vitamin D and 10 mg of zinc or placebo group, during 24 weeks. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomly allocated to two groups (vitamin supplement or placebo), with a duration of 24 weeks. Dietary and compliance monthly follow-up and baseline, 12 and 24-week measurements.
| Arm | Type | Receives |
|---|---|---|
| Vitamin supplement | Experimental | Dietary Supplement: Vitamin SupplementEffervescent tablets containing Vitamin C, Vitamin D and zinc |
| Placebo | Placebo comparator | Other: PlaceboEffervescent tablets not containing Vitamin C, Vitamin D and zinc |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 25 and 55 years of age, as this is the age in which type 2 diabetes mellitus is more prevalent and there is less probability of encountering multiple diseases in the same subjects
- Both sexes
- Outpatients
- BMI ≥ 25
Key exclusion criteria (15 listed)
- Without any other chronic disease (cancer, cardiovascular diseases, arthritis and Alzheimer's).
- Severe renal insufficiency.
- Nephrolithiasis or history of nephrolithiasis.
- Hyperoxaluria.
- Hemochromatosis.
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 SupplementSubjects will be randomly allocated to a supplementation of vitamin C 1000mg, vitamin D 400 IU and zinc 10 mg or an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding | Dietary supplement | Vitamin supplement |
| PlaceboSubjects will be randomly allocated to a supplementation of an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding | Other | Placebo |
Primary outcome
Change in glycemia from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL
Change in glycosilated Hemoglobin (Hb1Ac) from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Measured in plasma with a Selectra II automated equipment with Randox reactants, in percentage
Change in plasma insulin from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in uU/mL
Change in Homeostatic Model Assesment for Insulin Resistance (HOMA-IR) from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Calculated from: HOMA-IR = (insulin x glucose)/405
7 secondary outcomes
Change in plasma cytokines from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Change in plasma adipokines from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Change in additional plasma inflammatory markers from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Change in lipid profile from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Changes in markers of oxidative stress from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Changes in lymphocyte subpopulations from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Changes in Intestinal microbiota patterns from baseline to 12 and 24 weeks
Time frame: Baseline, 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Vitamin Supplement in people with Diabetes Mellitus, Type 2, run by Universidad Autonoma del Estado de 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 15 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: status not confirmed, as of the sponsor's last update on 1 Oct 2019. 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?
Results are not available in the source record.
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 glycemia from baseline to 12 and 24 weeks (time frame: Baseline, 12 and 24 weeks). The study lists 4 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 1 Oct 2019.