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A randomised controlled trial evaluating the impact of targeted vitamin D supplementation on endothelial function in type 2 diabetes mellitus: The DIMENSION trial.

Dalan R, Liew H, Assam PN, Chan ES, Siddiqui FJ, Tan AW, Chew DE, Boehm BO, Leow MK - Diab Vasc Dis Res (2016)

Bottom Line: We compared the change from baseline parameters in the two groups using Student's t-test or Kruskal-Wallis test.The median reactive hyperaemia index in the vitamin D group increased from 0.65 (interquartile range: 0.42) to 0.73 (interquartile range: 0.36), whereas it decreased from 0.73 (interquartile range: 0.65) to 0.65 (interquartile range: 0.38) (p = 0.02) in the placebo group.After adjustment for baseline variables, the change was not statistically significant for reactive hyperaemia index (p = 0.07) and for other vascular biomarkers (p > 0.05).

View Article: PubMed Central - PubMed

Affiliation: Department of Endocrinology, Tan Tock Seng Hospital, Singapore Yong Loo Lin School of Medicine, National University of Singapore, Singapore DUKE-NUS Medical School, National University of Singapore, Singapore Metabolic Medicine Research Program, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore rinkoo_dalan@ttsh.com.sg.

No MeSH data available.


Related in: MedlinePlus

Flowchart for subject participation.
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Related In: Results  -  Collection

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fig1-1479164115621667: Flowchart for subject participation.

Mentions: The study was a randomised, double-blind, placebo-controlled, parallel group trial. Figure 1 shows the patient participation flow chart: 104 patients were screened and 64 were randomly allocated into blocks of six to cholecalciferol or placebo. Patients were randomised in a 1:1 allocation ratio using a computer-generated random number sequence and allocated to either the vitamin D or placebo group using a centralised interactive password-protected web-based service, to ensure allocation concealment of patient enrollers. The study team and patients were blinded using placebo tablets (excipient without active ingredient) that appeared identical to the active tablets [each tablet 1000 International Unit (IU)]. Both types of tablets were manufactured, labelled and blinded in the same run in blocks of six, by D3 Pharmacy, Denmark (DK-9000 Aalborg), and imported by OneNine57 Pte Ltd. If the patient’s baseline 25(OH)D was ⩽20 ng/mL (50 nmol/L), they were started on four tablets of cholecalciferol (4000 IU) or matching placebo daily. If the baseline 25(OH)D was 21–30 ng/mL (51–75 nmol/L), they were started on two tablets of cholecalciferol (2000 IU) or matching placebo daily. All the patients had 25(OH)D concentrations measured at 8 weeks (interim visit). These were reviewed by an independent clinical research associate and the study dose was adjusted to half the initial dose (using matching placebo pills) if 25(OH)D was >30 ng/mL (75 nmol/L). Compliance was assessed by the percentage of prescribed pills ingested. A compliance rate of more than 80% was considered satisfactory. The trial ended upon completion of recruitment of 64 patients allowing for dropouts. The last patient was recruited on 28 January 2014 and completed follow-up on 20 May 2014.


A randomised controlled trial evaluating the impact of targeted vitamin D supplementation on endothelial function in type 2 diabetes mellitus: The DIMENSION trial.

Dalan R, Liew H, Assam PN, Chan ES, Siddiqui FJ, Tan AW, Chew DE, Boehm BO, Leow MK - Diab Vasc Dis Res (2016)

Flowchart for subject participation.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2 - License 3
Show All Figures
getmorefigures.php?uid=PMC4834510&req=5

fig1-1479164115621667: Flowchart for subject participation.
Mentions: The study was a randomised, double-blind, placebo-controlled, parallel group trial. Figure 1 shows the patient participation flow chart: 104 patients were screened and 64 were randomly allocated into blocks of six to cholecalciferol or placebo. Patients were randomised in a 1:1 allocation ratio using a computer-generated random number sequence and allocated to either the vitamin D or placebo group using a centralised interactive password-protected web-based service, to ensure allocation concealment of patient enrollers. The study team and patients were blinded using placebo tablets (excipient without active ingredient) that appeared identical to the active tablets [each tablet 1000 International Unit (IU)]. Both types of tablets were manufactured, labelled and blinded in the same run in blocks of six, by D3 Pharmacy, Denmark (DK-9000 Aalborg), and imported by OneNine57 Pte Ltd. If the patient’s baseline 25(OH)D was ⩽20 ng/mL (50 nmol/L), they were started on four tablets of cholecalciferol (4000 IU) or matching placebo daily. If the baseline 25(OH)D was 21–30 ng/mL (51–75 nmol/L), they were started on two tablets of cholecalciferol (2000 IU) or matching placebo daily. All the patients had 25(OH)D concentrations measured at 8 weeks (interim visit). These were reviewed by an independent clinical research associate and the study dose was adjusted to half the initial dose (using matching placebo pills) if 25(OH)D was >30 ng/mL (75 nmol/L). Compliance was assessed by the percentage of prescribed pills ingested. A compliance rate of more than 80% was considered satisfactory. The trial ended upon completion of recruitment of 64 patients allowing for dropouts. The last patient was recruited on 28 January 2014 and completed follow-up on 20 May 2014.

Bottom Line: We compared the change from baseline parameters in the two groups using Student's t-test or Kruskal-Wallis test.The median reactive hyperaemia index in the vitamin D group increased from 0.65 (interquartile range: 0.42) to 0.73 (interquartile range: 0.36), whereas it decreased from 0.73 (interquartile range: 0.65) to 0.65 (interquartile range: 0.38) (p = 0.02) in the placebo group.After adjustment for baseline variables, the change was not statistically significant for reactive hyperaemia index (p = 0.07) and for other vascular biomarkers (p > 0.05).

View Article: PubMed Central - PubMed

Affiliation: Department of Endocrinology, Tan Tock Seng Hospital, Singapore Yong Loo Lin School of Medicine, National University of Singapore, Singapore DUKE-NUS Medical School, National University of Singapore, Singapore Metabolic Medicine Research Program, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore rinkoo_dalan@ttsh.com.sg.

No MeSH data available.


Related in: MedlinePlus