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      The Efficacy and Safety of a High Dose of Vitamin D in Mothers with Gestational Diabetes Mellitus: A Randomized Controlled Clinical Trial

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          Abstract

          Background: During pregnancy and lactation outstanding changes occur in mother’s vitamin D metabolism. This study was carried out to evaluate the efficacy of 300,000 IU vitamin D given intramuscularly on body status in new cases of gestational diabetes mellitus (GDM).

          Methods: This is a randomized clinical trial with the follow-up period of 3 months. Totally 45 participants were randomly divided into intervention group (IG) and control group (CG). The IG received an IM injection of 300,000 IU of vitamin D, whereas CG did not. The glycosylated hemoglobin A1C (HBA1C), serum 25-OH-D, parathyroid hormone (PTH), serum calcium and phosphorus were measured.

          Results: Forty five patients including 24 with the mean age of 30.7±6.2 years in the IG and 21 with the mean age of 29.5±4.0 years in the CG participated in the study. The median concentration of serum 25(OH)D3 in the IG was to 62.10 nmol/l after the intervention, showing an increase of around 158%, compared to before intervention (24.25 nmol/l) whereas the CG showed a decrease of around 4.5%. Of the patients, 79.2% of IG and 81.9% of CG suffered to some degree from vitamin D deficiency. These figures were 4.2% and 71.4% for the IG and CG, respectively after the intervention.

          For the IG, the PTH was significantly lower and Ca was significantly higher after the intervention. The serum Phosphorus before and after the intervention in each group or between the two groups was not significant.

          Conclusions: The single 300,000 IM dose of vitamin D is regarded as an effective and safe to promptly improve vitamin D status in GDM.

          Trial Registration Number: IRCT138902113840N1

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          Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial.

          Kerrie M Sanders, Amanda Stuart, Elizabeth Williamson … (2010)
          Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures; however, adherence to daily supplementation is typically poor. To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture. A double-blind, placebo-controlled trial of 2256 community-dwelling women, aged 70 years or older, considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were randomly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years. The study concluded in 2008. 500,000 IU of cholecalciferol or placebo. Falls and fractures were ascertained using monthly calendars; details were confirmed by telephone interview. Fractures were radiologically confirmed. In a substudy, 137 randomly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels. Women in the cholecalciferol (vitamin D) group had 171 fractures vs 135 in the placebo group; 837 women in the vitamin D group fell 2892 times (rate, 83.4 per 100 person-years) while 769 women in the placebo group fell 2512 times (rate, 72.7 per 100 person-years; incidence rate ratio [RR], 1.15; 95% confidence interval [CI], 1.02-1.30; P = .03). The incidence RR for fracture in the vitamin D group was 1.26 (95% CI, 1.00-1.59; P = .047) vs the placebo group (rates per 100 person-years, 4.9 vitamin D vs 3.9 placebo). A temporal pattern was observed in a post hoc analysis of falls. The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months (test for homogeneity; P = .02). In the substudy, the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3% of the substudy participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group, 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L, were approximately 90 nmol/L at 3 months, and remained higher than the placebo group 12 months after dosing. Among older community-dwelling women, annual oral administration of high-dose cholecalciferol resulted in an increased risk of falls and fractures. anzctr.org.au Identifier: ACTRN12605000658617; isrctn.org Identifier: ISRCTN83409867.
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            Role of vitamin D in the pathogenesis of type 2 diabetes mellitus.

            F. Blanco, Maria Mauricio, Ketty Gonzalez … (2008)
            Vitamin D deficiency has been shown to alter insulin synthesis and secretion in both humans and animal models. It has been reported that vitamin D deficiency may predispose to glucose intolerance, altered insulin secretion and type 2 diabetes mellitus. Vitamin D replenishment improves glycaemia and insulin secretion in patients with type 2 diabetes with established hypovitaminosis D, thereby suggesting a role for vitamin D in the pathogenesis of type 2 diabetes mellitus. The presence of vitamin D receptors (VDR) and vitamin D-binding proteins (DBP) in pancreatic tissue and the relationship between certain allelic variations in the VDR and DBP genes with glucose tolerance and insulin secretion have further supported this hypothesis. The mechanism of action of vitamin D in type 2 diabetes is thought to be mediated not only through regulation of plasma calcium levels, which regulate insulin synthesis and secretion, but also through a direct action on pancreatic beta-cell function. Therefore, owing to its increasing relevance, this review focuses on the role of vitamin D in the pathogenesis of type 2 diabetes mellitus.
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              Maternal Plasma 25-Hydroxyvitamin D Concentrations and the Risk for Gestational Diabetes Mellitus

              CUILIN ZHANG, Chunfang Qiu, Frank Hu … (2008)
              Background Evidence is accumulating for a role of vitamin D in maintaining normal glucose homeostasis. However, studies that prospectively examined circulating concentrations of 25-hydroxyvitamin D (25-[OH] D) in relation to diabetes risk are limited. Our objective is to determine the association between maternal plasma 25-[OH] D concentrations in early pregnancy and the risk for gestational diabetes mellitus (GDM). Methods A nested case-control study was conducted among a prospective cohort of 953 pregnant women. Among them, 57 incident GDM cases were ascertained and 114 women who were not diagnosed with GDM were selected as controls. Controls were frequency matched to cases for the estimated season of conception of the index pregnancy. Results Among women who developed GDM, maternal plasma 25-[OH] D concentrations at an average of 16 weeks of gestation were significantly lower than controls (24.2 vs. 30.1 ng/ml, P<0.001). This difference remained significant (3.62 ng/ml lower on average in GDM cases than controls (P value = 0.018)) after the adjustment for maternal age, race, family history of diabetes, and pre-pregnancy BMI. Approximately 33% of GDM cases, compared with 14% of controls (P<0.001), had maternal plasma 25-[OH] D concentrations consistent with a pre-specified diagnosis of vitamin D deficiency (<20 ng/ml). After adjustment for the aforementioned covariates including BMI, vitamin D deficiency was associated with a 2.66-fold (OR (95% CI): 2.66 (1.01–7.02)) increased GDM risk. Moreover, each 5 ng/ml decrease in 25-[OH] D concentrations was related to a 1.29-fold increase in GDM risk (OR (95% CI): 1.29 (1.05–1.60)). Additional adjustment for season and physical activity did not change findings substantially. Conclusions Findings from the present study suggest that maternal vitamin D deficiency in early pregnancy is significantly associated with an elevated risk for GDM.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Iran J Med Sci
                Journal ID (iso-abbrev): Iran J Med Sci
                Journal ID (publisher-id): IJMS
                Title: Iranian Journal of Medical Sciences
                Publisher: Shiraz University of Medical Sciences (Shiraz, Iran )
                ISSN (Print): 0253-0716
                ISSN (Electronic): 1735-3688
                Publication date (Print): September 2012
                Volume: 37
                Issue: 3
                Pages: 159-165
                Affiliations
                [1 ]Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
                [2 ]Department of Internal Medicine, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
                [3 ]Department of Immunology, Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
                [4 ]Department of English Language, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
                Author notes
                Correspondence: Hassan Mozaffari-Khosravi PhD, Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Daneshjo Boulevard, Yazd, Iran. Tel: +98 351 7249333, Fax: +98 351 7258413, Email: Mozaffari.kh@gmail.com
                Article
                Publisher ID: IJMS-37-159
                PMC ID: 3470091
                PubMed ID: 23115447
                SO-VID: 9e5acbf7-b1b7-4028-abff-3810e0b463c4
                Copyright © © 2012 Iranian Journal of Medical Sciences
                History
                Date received : 2 August 2011
                Date revision received : 25 September 2011
                Date accepted : 30 October 2011
                Categories
                Subject: Original Article

                ScienceOpen disciplines: Medicine
                Keywords: vitamin d,cholecalciferol,gestational diabetes mellitus
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: vitamin d, cholecalciferol, gestational diabetes mellitus

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