Dataset Information

Randomized trial of three doses of vitamin D to reduce deficiency in pregnant Mongolian women.

ABSTRACT:

Background

In winter in Mongolia, 80% of adults have 25-hydroxyvitamin D (25(OH)D) concentrations <25 nmol/l (<10 ng/ml) and 99% have <50 nmol/l (<20 ng/ml). The vitamin D dose to avert deficiency during pregnancy in this population is unknown.

Methods

We conducted a randomized, controlled, double-blind trial of daily 600, 2000, or 4000 IU vitamin D₃ for pregnant women in Mongolia (Clinicaltrials.gov #NCT02395081). We examined 25(OH)D concentrations at baseline (12-16 weeks' gestation), 36-40 weeks' gestation and in umbilical cord blood, using enzyme linked fluorescent assay. Sample size was determined to detect 0.4 standard deviation differences in 25(OH)D concentrations with 80% power.

Findings

119 pregnant women were assigned 600 IU, 121 assigned 2000 IU and 120 assigned 4000 IU from February 2015 through December 2016. Eighty-eight percent of participants took ≥80% of assigned supplements. At baseline, 25(OH)D concentrations were similar across arms; overall mean ± standard deviation concentration was 19 ± 22 nmol/l; 91% were < 50 nmol/l. At 36-40 weeks, 25(OH)D concentrations increased to 46 ± 21, 70 ± 23, and 81 ± 29 nmol/l for women assigned 600, 2000, and 4000 IU, respectively (p < 0.0001 across arms; p = 0.002 for 2000 vs. 4000 IU). Mean umbilical cord 25(OH)D concentrations differed by study arm (p < 0.0001 across arms; p < 0.0001 for 2000 vs. 4000 IU) and were proportional to maternal concentrations. There were no adverse events, including hypercalcemia, attributable to vitamin D supplementation.

Interpretation

Daily supplementation of 4000 IU during pregnancy is safe and achieved higher maternal and neonatal 25(OH)D concentrations than 2000 IU. Daily 600 IU supplements are insufficient to prevent vitamin D deficiency in Mongolia. FUND: Anonymous foundation and Brigham and Women's Hospital.

SUBMITTER: Enkhmaa D

PROVIDER: S-EPMC6354654 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Randomized trial of three doses of vitamin D to reduce deficiency in pregnant Mongolian women.

Enkhmaa D D Tanz L L Ganmaa D D Enkhtur Sh S Oyun-Erdene B B Stuart J J Chen G G Carr A A Seely E W EW Fitzmaurice G G Buyandelger Yo Y Sarantsetseg B B Gantsetseg G G Rich-Edwards J J

EBioMedicine 20181211

<h4>Background</h4>In winter in Mongolia, 80% of adults have 25-hydroxyvitamin D (25(OH)D) concentrations <25 nmol/l (<10 ng/ml) and 99% have <50 nmol/l (<20 ng/ml). The vitamin D dose to avert deficiency during pregnancy in this population is unknown.<h4>Methods</h4>We conducted a randomized, controlled, double-blind trial of daily 600, 2000, or 4000 IU vitamin D<sub>3</sub> for pregnant women in Mongolia (Clinicaltrials.gov #NCT02395081). We examined 25(OH)D concentrations at baseline (12-16 w ...[more]

PMID: 30552064

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Project description:Vitamin A plays an important role in the periods of rapid cellular growth and differentiation, especially during pregnancy, which is supplied by the mother to the fetus. The aim of this study is to assess the prevalence and potential influence factors of prenatal VAD of Chinese pregnant women.China National Nutrition and Health Survey 2010-2013(CHNNS2010-2013) is a nationally representative cross-sectional study. It involved the random selection of 150 districts (urban) or counties (rural). Each site randomly selected 30 pregnant women. Because volume of blood and incomplete data was taken into consideration,the final sample was formed by 1209 participants. Serum retinol concentrations were measured by high performance liquid chromatography. Characteristics of the pregnant women were collected by a questionnaire. Comparing retinol level across categories of independent variables was tested by the Mann-Whitney U test. Logistic and linear regression analyses were used to identify influence factors of Chinese pregnant women.The mean serum retinol level of the pregnant women was 1.63 μmol/L (95 % CI 1.60-1.67) and 64[5.3 % (95 % CI 4.03-6.56)] had VAD. The odds of VAD were significantly higher among the pregnant women in the poor rural areas and without college or university education and low- income. Pregnant women in the second and third trimester had 2.40 (95 % CI 1.05-5.46) and 2.82 (95 % CI 1.34-5.93) times increased odds of VAD compared with those in the first trimester respectively. Pregnant women of drinker had 3.10(1.65-5.81) times increased odds of VAD compared with those no drinker. Pregnant smokers had 5.68 (95 % CI 2.23-14.49) times higher odds of VAD compared with pregnant with non-smoker without passive smoking.VAD is of mild public-health issue in Chinese pregnant women. Such as : in the poor rural areas and without received college or university education and low- income and advanced gestational age and unhealthy lifestyles of pregnant women such as smoking and drinking. These were pertinent influence factors of VAD.

Project description:BackgroundHypovitaminosis D in pregnancy is associated with adverse health outcomes in mothers, newborns and infants. This study assessed the levels of 25-hydroxyvitamin D [25(OH)D] in normotensive pregnancies and in preeclampsia, evaluated the association between vitamin D deficiency and preeclampsia risk; and determined the foeto-maternal outcome in preeclamptic women with vitamin D deficiency.MethodsThis case-control study was conducted among pregnant women who visited the Comboni Hospital, in Ghana from January 2017 to May 2018 for antenatal care. A total of 180 pregnant women comprising 88 preeclamptic women (PE) and 92 healthy normotensive pregnant women (NP) were recruited. Socio-demographic, clinical and obstetric data were obtained using validated questionnaires. Blood pressure and anthropometrics were measured, and blood samples were collected for the estimation of 25- hydroxyvitamin D [25(OH)D] using enzyme-linked immunosorbent assay technique. Lipids (total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol) were also estimated.ResultsA total of 81.7% of the study participants had vitamin D deficiency. Of these, 88.6% of the women with PE had vitamin D deficiency compared to 75.0% in the NP. Vitamin D levels were significantly reduced in the PE women compared to the normotensive pregnant women (p = 0.001). A higher proportion of the preeclamptic women who were vitamin D deficient had preterm delivery (p < 0:0001) and delivered low birth weight infants (p < 0:0001), and infants with IUGR (p < 0:0001) compared to the control group (p < 0:0001). Pregnant women with PE presented with significant dyslipidemia, evidenced by significantly elevated TC (p = 0.008), LDL (p < 0.0001), triglycerides (p = 0.017) and a significantly reduced HDL (p = 0.001) as compared to NP. In the preeclamptic women, serum 25(OH) D showed an inverse, but not significant association with TC (β = - 0.043, p = 0.722, TG (β = - 0.144, p = 0.210) and LDL (β = - 0.076, p = 0.524) and a positive, but not significant association with HDL (β = 0.171, p = 0.156).ConclusionThe prevalence of vitamin D deficiency is high in both normotensive pregnancies and pregnancies complicated by preeclampsia but amplified in preeclampsia. Higher proportion of pregnant women with hypovitaminosis D had preterm babies and delivered low birth weight neonates. Additional studies are needed to explore the potential benefits and optimal dosing of vitamin D use in pregnancy, especially in sub-Saharan Africa.

Project description:BackgroundThe achievement of target 25-hydroxyvitamin D [25(OH)D] concentrations in pregnancy may be altered by maternal obesity.ObjectiveThe authors examined the effects of maternal supplementation of 10 μg compared with 20 μg vitamin D3/d on maternal and umbilical cord 25(OH)D. The secondary aim was to investigate the influence of maternal BMI (in kg/m2) on the response of the primary outcomes.MethodsThe authors performed a 2-arm parallel double-blind randomized trial with 240 pregnant women recruited throughout the year in Northern Ireland. Women were stratified by BMI to receive 10 or 20 µg vitamin D3/d from 12 gestational wk (GW) until delivery. Maternal blood samples collected at 12, 28, and 36 GW and from the umbilical cord were analyzed for total serum 25(OH)D. A total of 166 women completed the study.ResultsMean ± SD 25(OH)D at 36 GW was 80.8 ± 28.2 compared with 94.4 ± 33.2 nmol/L (P < 0.001) (10 compared with 20 µg vitamin D3/d, respectively). In those classified with 25(OH)D <50 nmol/L at baseline and assigned 10 µg vitamin D3/d, mean 25(OH)D concentrations remained <50 nmol/L at 36 GW, whereas those <50 nmol/L at baseline and assigned 20 µg vitamin D3/d, had mean 25(OH)D concentrations ≥50 nmol/L at 28 and 36 GW. In women with obesity and 25(OH)D <50 nmol/L at baseline, the related mean umbilical cord 25(OH)D was deficient (<25 nmol/L) in both treatment groups, whereas those with obesity and 25(OH)D ≥50 nmol/L at baseline had an average umbilical cord 25(OH)D between 25 and 50 nmol/L in both treatment groups.ConclusionsSupplementation of 20 µg vitamin D3/d is needed to attain maternal and umbilical cord 25(OH)D concentrations ≥50 nmol/L on average, in those who start pregnancy with low 25(OH)D concentrations (<50 nmol/L). Under current recommendations, women with obesity and low 25(OH)D in early pregnancy are particularly vulnerable to maintaining a low 25(OH)D concentration throughout pregnancy and having an infant born with deficient 25(OH)D concentrations. This trial was registered at ClinicalTrials.gov as NCT02713009.

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Dataset Information

Randomized trial of three doses of vitamin D to reduce deficiency in pregnant Mongolian women.

Background

Methods

Findings

Interpretation

Publications

Randomized trial of three doses of vitamin D to reduce deficiency in pregnant Mongolian women.

Similar Datasets

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