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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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20 August 2018 |
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Main ID: |
ISRCTN97792326 |
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Date of registration:
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24/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the effect of supplementation with omega-3 fatty acids and vitamin D on blood sugar, lipids, cholesterol and inflammation markers, and body weight, in patients with diabetes mellitus
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Scientific title:
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Effect of omega-3 fatty acid supplementation and vitamin D on the immuno-inflammatory process in patients with type 2 diabetes mellitus in Mexico |
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Date of first enrolment:
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01/03/2015 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN97792326 |
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Study type:
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Interventional |
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Study design:
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Placebo-controlled cluster randomised trial (Prevention)
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Phase:
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Roxana
Valdes-Ramos |
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Address:
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Paseo Tollocan esq. Jesús Carranza
Col. Moderna de la Curz
50180
Toluca
Mexico |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Diagnosed type 2 diabetes mellitus
2. Age between 25 and 55 years
3. BMI = 29.9
4. With no other chronic pathology
5. No insulin treatment
6. HOMA = 2.4
Exclusion criteria: 1. Pregnancy or lactation
2. Non-mixed Mexican origin (native or immigrants)
3. Lack of data from measurements
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
Nutritional, Metabolic, Endocrine
Type 2 Diabetes Mellitus
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Intervention(s)
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Participating health clinics are randomised to one of four groups.
Group 1: Participants receive three gelcaps (Vitamin D-3 General Nutrition Centers™) daily, to be consumed one per meal time, with a total of 3300mg of fatty acids as follows: EPA 765 mg and DHA 240 mg per capsule.
Group 2: Participants receive three gelcaps (Fish Oil 1000 General Nutrition Centers™) daily, to be consumed one per meal time, with a total of 3000 IU of vitamin D3, each containing Cholecalciferol (equivalent to 1000 IU of Vitamin D3) 0.250mg.
Group 3: Participants receive three gelcaps (Vitamin D-3 General Nutrition Centers™) daily, to be consumed one per meal time, with a total of 3300mg of fatty acids as follows: EPA 765 mg and DHA 240 mg per capsule, and three gelcaps (Fish Oil 1000 General Nutrition Centers™) daily, to be consumed one per meal time, with a total of 3000 IU of vitamin D3, each containing Cholecalciferol (equivalent to 1000 IU of Vitamin D3) 0.250mg. That is one capsule of each supplement per meal time for a total of six per day.
Group 4: Participants receive three capsules filled with cornstarch per day, to be consumed one per meal time.
Once the patients were assigned to the supplement groups, they were called to attend their clinic for the baseline evaluation and given their four-week supplements and their subsequent appointment. At every four-week appointment, patients underwent a 24-food recall, the two adherence tests and received their next four-week supplement flasks. The treatment lasted 24 weeks, at the time when they were given their last appointment for final evaluation.
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Primary Outcome(s)
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1. Glucose (Cat. GL1611), glycosylated haemoglobin (Cat.HA3830A), total cholesterol (Cat. CHO215), HDL-cholesterol (Cat. CH3811A), LDL (Cat. CH3811B) & triacylglycerides (Cat. Tr213) are assessed using an ultrasensitive colorimetric method in an automated Selectra II equipment, with commercial RANDOX™ reactants. VLDL was calculated with the Friedwald equation (Friedwald et.al. 1972). All measurements were done at baseline and 24 weeks
2. Plasma fatty acids are measured using chromatography and methylation at baseline and 24 weeks
3. Vitamin D and insulin are measured using a commercial ELISA kit from R&D Systems (Cat. 51081) assay at baseline and 24 weeks
4. Cytokines are assessed using Milliplex Human Citokine Five Plex (Cat. MPXHCYTO-60K-05) for TNFa, IFN-?, IL-1ß, IL4 and IL10 and the Milliplex Human Citokine One Plex (Cat. MPXHCYTO-B-01) for TGF- ß, at baseline and 24 weeks
5. Adipokines Adiponectin, Resistin and Leptin levels are assessed with the Milliplex Human Adipokine Magnetic Bead Panel (Cat.HADK1-61K-02 and Cat.HADK1-61K-01) at baseline and 24 weeks
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Secondary Outcome(s)
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1. Dietary intake is assessed through 24-hour dietary recall at baseline and every four weeks until the final evaluation at 24 weeks
2. Anthropometry (weight, height, BMI) is assessed with a portable stadiometer and weighing scale at baseline and 24 weeks
3. Treatment adherence is assessed with the Morinksey-Green and Haynes-Sackett tests every four weeks from baseline to week 24
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Secondary ID(s)
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UAEM 212946
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Source(s) of Monetary Support
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Consejo Nacional de Ciencia y Tecnología (CONACyT)
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Ethics review
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Status:
Approval date:
Contact:
Ethics and Research Committes of the Faculty of Medicine of the Universidad Autónoma del Estado de México, 31/01/2013
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/12/2016 |
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URL:
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