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

Ahmed A Madar; Kirsten V Knutsen; Lars C Stene; Mette Brekke; Haakon E Meyer; Per Lagerløv

doi:10.1136/bmjdrc-2014-000026

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

BMJ Open Diabetes Res Care. 2014 Oct 13;2(1):e000026. doi: 10.1136/bmjdrc-2014-000026. eCollection 2014.

Authors

Ahmed A Madar¹, Kirsten V Knutsen², Lars C Stene³, Mette Brekke², Haakon E Meyer⁴, Per Lagerløv²

Affiliations

¹ Department of Community Medicine , Institute of Health and Society, University of Oslo , Oslo , Norway.
² Department of General Practice , Institute of Health and Society, University of Oslo , Oslo , Norway.
³ Division of Epidemiology , Norwegian Institute of Public Health , Oslo , Norway.
⁴ Department of Community Medicine , Institute of Health and Society, University of Oslo , Oslo , Norway ; Division of Epidemiology , Norwegian Institute of Public Health , Oslo , 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.

Keywords: Body Mass Index; Glycated Hemoglobin; Serum Lipids; Vitamin D.

Associated data

ClinicalTrials.gov/NCT01263288