Dataset Information

Effect of vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, serum lipids, and body mass index: a randomized, double-blinded, placebo-controlled trial among healthy immigrants living in Norway.

ABSTRACT:

Objective

Despite the suggested role of vitamin D in the prevention of diabetes and cardiovascular disease or its risk factors, the evidence is not consistent and there is a paucity of randomized controlled trials in this field. We aimed to investigate the effect of 16-week daily vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, body mass index (BMI), and serum lipids.

Design

Double-blind, randomized, placebo-controlled trial.

Setting

Immigrant community centers in Oslo, Norway.

Participants

251 healthy adults aged 18-50 years with a non-Western immigrant background. All participants performed the baseline test and 215 (86%) returned to the follow-up test.

Intervention

16 weeks of daily oral supplementation with either 10 μg vitamin D3, 25 μg vitamin D3, or placebo.

Main outcome measures

Difference in absolute change during the 16-week intervention between the intervention groups combined (10 or 25 μg of vitamin D3/day) and placebo, in HbA1c, fructosamine, serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), and BMI.

Results

A total of 215 (86%) participants completed the study. Serum 25-hydroxyvitamin D increased from 29 nmol/L at baseline to 49 nmol/L after intervention, with little change in the placebo group. However, there was no difference in change of HbA1c between those receiving vitamin D3 compared with placebo (mean difference: 0.01% (95% CI -0.04 to 0.06, p=0.7)). Neither did the vitamin D3 supplementation have any effect on the other end points: fructosamine, serum lipids, and BMI.

Conclusions

16-week vitamin D3 supplementation to healthy immigrants from South Asia, the Middle East, or Africa and now living in Norway with low vitamin D status did not improve HbA1c, fructosamine, lipid profiles, or BMI. An updated meta-analysis of similar published trials showed that our results were generally consistent with those of other studies.

Trial registration number

NCT01263288.

SUBMITTER: Madar AA

PROVIDER: S-EPMC4212570 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, serum lipids, and body mass index: a randomized, double-blinded, placebo-controlled trial among healthy immigrants living in Norway.

Madar Ahmed A AA Knutsen Kirsten V KV Stene Lars C LC Brekke Mette M Meyer Haakon E HE Lagerløv Per P

BMJ open diabetes research & care 20141013 1

<h4>Objective</h4>Despite the suggested role of vitamin D in the prevention of diabetes and cardiovascular disease or its risk factors, the evidence is not consistent and there is a paucity of randomized controlled trials in this field. We aimed to investigate the effect of 16-week daily vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, body mass index (BMI), and serum lipids.<h4>Design</h4>Double-blind, randomized, placebo-controlled trial.<h4>Setting</h4>Immigrant commun ...[more]

PMID: 25452867

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Project description:IntroductionGlycemic control is important to avoid diabetes complications in individuals with cancer. There is no evidence for HbA1c and fructosamine as reliable biomarkers in these conditions. There are particularities in caring for patients with diabetes and cancer that can alter these biomarkers.ObjectiveThe aim of this study was to evaluate HbA1c and fructosamine as glycemic biomarkers in people with type 2 diabetes and cancer, undergoing clinical or surgical oncological treatment.MethodsThe authors conducted a single-center, retrospective analysis with people who have cancer and diabetes. Comparison of glycemic biomarkers (HbA1c, fructosamine, and Self-Monitoring of Blood Glucose [SMBG]) was performed including evaluation in individuals undergoing chemotherapy, using glucocorticoids, with anemia, hypoproteinemia or with reduced estimated Glomerular Filtration Rate (eGFR).ResultsThere was a strong positive correlation between fructosamine and HbA1c (n = 318, r = 0.66, p < 0.001) in people with diabetes and cancer even in those under chemotherapy (n = 101, r = 0.61, p < 0.001) or using glucocorticoids (n = 96, r = 0.67, p<0.001). There was a strong correlation between HbA1c and fructosamine in subjects with anemia (n = 111, r = 0.66, p < 0.001), hypoproteinemia (n = 54, r = 0.67, p < 0.001), or with eGFR ≥ 60 mL/min/1.73 m2 (n = 189, r = 0.70, p < 0.001), and moderate correlation with hypoalbuminemia (n = 21, r = 0.54, p = 0.001) and with reduced eGFR (n = 67, r = 0.57, p < 0.001). The correlations between fructosamine and HbA1c with SMBG were moderate (n = 164, r = 0.49, p < 0.001; n = 111, r = 0.55, p < 0.001, respectively), strong in subjects undergoing chemotherapy, with hypoalbuminemia or hypoproteinemia, and at least moderate, if eGFR < 60 mL/min/1.73 m2 or with anemia.ConclusionsFructosamine and HbA1c can be used as glycemic biomarkers in people with diabetes and cancer, even in those with anemia, hypoproteinemia, or undergoing chemotherapy.

Project description:BackgroundWhile studies suggest impacts of individual environmental exposures on type 2 diabetes (T2D) risk, mechanisms remain poorly characterized. Glycated hemoglobin (HbA1c) is a biomarker of glycemia and diagnostic criterion for prediabetes and T2D. We explored associations between multiple environmental exposures and HbA1c in non-diabetic adults.MethodsHbA1c was assessed once in 12,315 women and men in three U.S.-based prospective cohorts: the Nurses' Health Study (NHS), Nurses' Health Study II (NHSII), and Health Professionals Follow-up Study (HPFS). Residential greenness within 270 m and 1,230 m (normalized difference vegetation index, NDVI) was obtained from Landsat. Fine particulate matter (PM2.5) and nitrogen dioxide (NO2) were estimated from nationwide spatiotemporal models. Three-month and one-year averages prior to blood draw were assigned to participants' addresses. We assessed associations between single exposure, multi-exposure, and component scores from Principal Components Analysis (PCA) and HbA1c. Fully-adjusted models built on basic models of age and year at blood draw, BMI, alcohol use, and neighborhood socioeconomic status (nSES) to include diet quality, race, family history, smoking status, postmenopausal hormone use, population density, and season. We assessed interactions between environmental exposures, and effect modification by population density, nSES, and sex.ResultsBased on HbA1c, 19% of participants had prediabetes. In single exposure fully-adjusted models, an IQR (0.14) higher 1-year 1,230 m NDVI was associated with a 0.27% (95% CI: 0.05%, 0.49%) lower HbA1c. In basic component score models, a SD increase in Component 1 (high loadings for 1-year NDVI) was associated with a 0.19% (95% CI: 0.04%, 0.34%) lower HbA1c. CI's crossed the null in multi-exposure and fully-adjusted component score models. There was little evidence of associations between air pollution and HbA1c, and no evidence of effect modification.ConclusionsAmong non-diabetic adults, environmental exposures were not consistently associated with HbA1c. More work is needed to elucidate biological pathways between the environment and prediabetes.

Dataset Information

Effect of vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, serum lipids, and body mass index: a randomized, double-blinded, placebo-controlled trial among healthy immigrants living in Norway.

Objective

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusions

Trial registration number

Publications

Effect of vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, serum lipids, and body mass index: a randomized, double-blinded, placebo-controlled trial among healthy immigrants living in Norway.

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