Dataset Information

Monthly Increase in Vitamin D Levels upon Supplementation with 2000 IU/Day in Healthy Volunteers: Result from "Integriamoci", a Pilot Pharmacokinetic Study.

ABSTRACT: Vitamin D (VD) is a calcium- and phosphate-controlling hormone used to treat bone disorders; yet, several other effects are progressively emerging. VD deficiency is highly prevalent worldwide, with suboptimal exposure to sunlight listed among the leading causes: oral supplementation with either cholecalciferol or calcitriol is used. However, there is a scarcity of clinical studies investigating how quickly VD concentrations can increase after supplementation. In this pilot study, the commercial supplement ImmuD3 (by Erboristeria Magentina®) was chosen as the source of VD and 2000 IU/day was administered for one month to 21 healthy volunteers that had not taken any other VD supplements in the previous 30 days. Plasma VD levels were measured through liquid chromatography coupled to tandem mass spectrometry after 7, 14, and 28 days of supplementation. We found that 95% of the participants had insufficient VD levels at baseline (<30 ng/mL; median 23.72 ng/mL; IQR 18.10-26.15), but after 28 days of supplementation, this percentage dropped to 62% (median 28.35 ng/mL; IQR 25.78-35.20). The median increase in VD level was 3.09 ng/mL (IQR 1.60-5.68) after 7 days and 8.85 ng/mL (IQR 2.85-13.97F) after 28 days. This study suggests the need for continuing VD supplementation and for measuring target level attainment.

SUBMITTER: Avataneo V

PROVIDER: S-EPMC8840528 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Monthly Increase in Vitamin D Levels upon Supplementation with 2000 IU/Day in Healthy Volunteers: Result from "Integriamoci", a Pilot Pharmacokinetic Study.

Avataneo Valeria V Palermiti Alice A De Nicolò Amedeo A Cusato Jessica J Giussani Gloria G Calcagno Andrea A D'Avolio Antonio A

Molecules (Basel, Switzerland) 20220203 3

Vitamin D (VD) is a calcium- and phosphate-controlling hormone used to treat bone disorders; yet, several other effects are progressively emerging. VD deficiency is highly prevalent worldwide, with suboptimal exposure to sunlight listed among the leading causes: oral supplementation with either cholecalciferol or calcitriol is used. However, there is a scarcity of clinical studies investigating how quickly VD concentrations can increase after supplementation. In this pilot study, the commercial ...[more]

PMID: 35164307

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Project description:IntroductionAlthough vitamin D is widely known as an essential micronutrient during pregnancy, the exact supplementation dose to prevent maternal-fetal outcomes remains a question. This study aims to provide a systematic review and a meta-analysis of data from randomized controlled trial on > 2000 IU/day vitamin D supplementation compared to ⩽ 2000 IU/day; and ⩽ 2000 IU/day compared to placebo, on their effects on the incidence of preeclampsia, gestational diabetes mellitus, preterm birth, and differences on birth weight.MethodsA systematic literature search on PubMed, EBSCO-MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases was carried out to evaluate randomized controlled trial studies on the effects of oral vitamin D > 2000 IU/day versus ⩽ 2000 IU/day; and ⩽ 2000 IU/day versus placebo, on preeclampsia, gestational diabetes mellitus, preterm birth and birth weight. Risk ratio, mean difference, and 95% confidence interval were calculated.ResultsThere were a total of 27 randomized controlled trials selected. Maternal vitamin D supplementation > 2000 IU/day had a positive effect only on gestational diabetes mellitus (seven randomized controlled trials; risk ratio = 0.70, 95% confidence interval: 0.51-0.95, I2 = 0). Vitamin D supplementation ⩽ 2000 IU/day has reduced the risk of preeclampsia (three randomized controlled trials; risk ratio = 0.29, 95% confidence interval: 0.09-0.95, I2 = 0), with no significant difference when compared to > 2000 IU/day (eight randomized controlled trials; risk ratio = 0.80, 95% confidence interval: 0.51-1.24, I2 = 31). No difference in preterm birth risk and birth weight after vitamin D supplementation. The quality of evidence varies from moderate to very low certainty. The risk of preeclampsia and gestational diabetes mellitus after high-dose versus low-dose vitamin D supplementation was the ones with moderate certainty.ConclusionVitamin D supplementation > 2000 IU/day might be important to reduce the risk of gestational diabetes mellitus. Lower dose vitamin D supplementation (⩽ 2000 IU/day) seemed adequate to reduce the risk of preeclampsia, with no significant difference compared to the higher dose.

Project description:Vitamin D plays a role in muscle function through genomic and non-genomic processes. The objective of this RCT was to determine the effect of monthly supplemental vitamin D3 onmuscle function in 70+ years old adults. Participants (n = 379) were randomized to receive, 12,000 IU, 24,000 IU or 48,000 IU of vitamin D3 monthly for 12 months. Standardized Hand Grip Strength (GS) and Timed-Up and Go (TUG) were measured before and after vitamin D3 supplementation. Fasting total plasma 25 hydroxyvitamin D (25OHD) and Parathyroid Hormone (PTH) concentrations were measured by Liquid Chromatography Tandem Mass Spectrometry (LC-MSMS) and immunoassay, respectively. Baseline plasma 25OHD concentrations were 41.3 (SD 19.9), 39.5 (SD 20.6), 38.9 (SD 19.7) nmol/L; GS values were 28.5 (SD 13.4), 28.8 (SD 13.0) and 28.1 (SD 12.1) kg and TUG test values were 10.8 (SD 2.5), 11.6 (SD 2.9) and 11.9 (SD 3.6) s for the 12,000 IU, 24,000 IU and 48,000 IU dose groups, respectively. Baseline plasma 25OHD concentration < 25 nmol/L was associated with lower GS (P = 0.003). Post-interventional plasma 25OHD concentrations increased to 55.9 (SD 15.6), 64.6 (SD15.3) and 79.0 (SD 15.1) nmol/L in the 12,000 IU, 24,000 IU and 48,000 IU dose groups, respectively and there was a significant dose-related response in post-interventional plasma 25OHD concentration (p<0.0001). Post-interventional GS values were 24.1 (SD 10.1), 26.2 (SD10.6) and 25.7 (SD 9.4) kg and TUG test values were 11.5 (SD 2.6), 12.0 (SD 3.7) and 11.9 (SD 3.2) s for 12,000 IU, 24,000 IU and 48,000 IU dose groups, respectively. The change (Δ) in GS and TUG from pre to post-intervention was not different between treatment groups before and after the adjustment for confounders, suggesting no effect of the intervention. Plasma 25OHD concentration was not associated with GS and TUG test after supplementation. In conclusion, plasma 25OHD concentration < 25 nmol/L was associated with lower GS at baseline. However, monthly vitamin D3 supplementation with 12,000 IU, 24,000 IU and 48,000 IU, for 12 months had no effect on muscle function in older adults aged 70+ years. Trial Registration : EudraCT 2011-004890-10 and ISRCTN35648481.

Project description:UNLABELLED:The randomised, double blind intervention trial 'Optimising Vitamin D Status in Older People' (VDOP) will test the effect of three oral dosages of vitamin D given for one year on bone mineral density (BMD) and biochemical markers of vitamin D metabolism, bone turnover and safety in older people. VDOP is funded by Arthritis Research UK, supported through Newcastle University and MRC Human Nutrition Research and sponsored by the Newcastle upon Tyne Hospitals NHS Foundation Trust.a BACKGROUND:Vitamin D insufficiency is common in older people and may lead to secondary hyperparathyroidism, bone loss, impairment of muscle function and increased risk of falls and fractures. Vitamin D supplementation trials have yielded conflicting results with regard to decreasing rates of bone loss, falls and fractures and the optimal plasma concentration of 25 hydroxy vitamin D (25OHD) for skeletal health remains unclear. METHOD/DESIGN:Older (?70 years) community dwelling men and women are recruited through General Practices in Northern England and 375 participants are randomised to take 12,000 international units (IU), 24,000 IU or 48,000 IU of vitamin D3 orally each month for one year starting in the winter or early spring. Hip BMD and anthropometry are measured at baseline and 12 months. Fasting blood samples are collected at baseline and three-month intervals for the measurement of plasma 25OHD, parathyroid hormone (PTH), biochemical markers of bone turnover and biochemistry to assess the dose-response and safety of supplementation. Questionnaire data include falls, fractures, quality of life, adverse events and outcomes, compliance, dietary calcium intake and sunshine exposure. DISCUSSION:This is the first integrated vitamin D supplementation trial in older men and women using a range of doses given at monthly intervals to assess BMD, plasma 25OHD, PTH and biochemical markers of bone turnover and safety, quality of life and physical performance. We aim to investigate the vitamin D supplementation and plasma 25OHD concentration required to maintain bone health and to develop a set of biochemical markers that reflects the effect of vitamin D on bone. This will aid future studies investigating the effect of vitamin D supplementation on fracture risk.#ISRCTN 35648481 (assigned 16 August 2012), EudraCT 2011-004890-10.

Project description:BackgroundThe appropriate dose of vitamin D supplementation in children is still debated. We calculated that the recommended dose of 600-1000 IU vitamin D3/day is not sufficient to reach a serum 25-hydroxyvitamin D (25-OH-D) level of at least 30 ng/ml (75 nmol/l) in north Italian children > 12 months. The aim of this study was to analyse the effect of seasonal supplementation with 1500 IU (=37.5 μg) vitamin D3/day.MethodsDINOS (D-vitamIN Oral Supplementation) study was a pilot, monocentric, non-random case-control register study. It was conducted in a paediatric primary care setting near Padova (North Italy, 45°N latitude). The data of 203 children (girls:boys 1:1,33) aged 2-15 years, collected between November 2010 and January 2015, were analysed. Active group A (n = 82) were given 1500 IU vitamin D3/day from November to April; control Group B (n = 121) received no supplementation. The serum 25-OH-D test was part of a laboratory tests panel and performed using a chemiluminescence immunoassay method.ResultsSerum 25-OH-D mean level + standard deviation throughout the period was 32 + 13 ng/ml (80 + 32 nmol/l) in group A vs 22 + 10 ng/ml (55 + 25 nmol/l) in group B. In group A 12% had vitamin D deficiency 25-OH-D < 20 ng/ml (50 nmol/l) and 1.2% severe vitamin D deficiency 25-OH-D < 10 ng/ml (25 nmol/l). In group B 46% had vitamin D deficiency and 9% severe deficiency (P < 0.001). In group A mean levels were normal or near-normal all the year except in May. Group B reached mean 25-OH-D levels close to 30 ng/ml (75 nmol/l) only in late summer. The active group mean 25-OH-D level was normal in preschoolers and schoolers but not in adolescents. Non-white children had a three-times vitamin D deficiency probability despite supplementation.ConclusionsVitamin D supplementation with at least 1500 IU vitamin D3/day from November to April was found appropriate for children in North Italy. A prolongation until May could be useful. Higher doses and/or prolonged periods could be more appropriate especially in adolescents and in non-white children.Study registrationDINOS gained the approval of Padova Ethics Committee (n. 3960/U16/2016).

Dataset Information

Monthly Increase in Vitamin D Levels upon Supplementation with 2000 IU/Day in Healthy Volunteers: Result from "Integriamoci", a Pilot Pharmacokinetic Study.

Publications

Monthly Increase in Vitamin D Levels upon Supplementation with 2000 IU/Day in Healthy Volunteers: Result from "Integriamoci", a Pilot Pharmacokinetic Study.

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