Dataset Information

A Randomized, Double-Blind, Parallel Study to Evaluate the Dose-Response of Three Different Vitamin D Treatment Schemes on the 25-Hydroxyvitamin D Serum Concentration in Patients with Vitamin D Deficiency.

ABSTRACT: Many people worldwide are vitamin D (VTD) deficient or insufficient, and there is still no consensus on the dose of VTD that should be administered to achieve a 25(OH)D concentration of 20 or 30 ng/mL. In this study, we aimed to determine an adapted supplementation of VTD able to quickly and safely increase the vitamin D status of healthy adults with low 25(OH)D. One hundred and fifty (150) subjects were randomized into three groups, each to receive, orally, a loading dose of 50,000, 100,000 or 200,000 IU of VTD3 at Week 0, followed by 25,000, 50,000 or 100,000 IU at Week 4 and Week 8. Whereas 25(OH)D baseline values were not different between groups (p = 0.42), a significant increase was observed at Week 12 (p < 0.0001) with a mean change from baseline of 7.72 ± 5.08, 13.3 ± 5.88 and 20.12 ± 7.79 ng/mL. A plateau was reached after eight weeks. No related adverse event was recorded. This study demonstrated a linear dose-response relationship with an increase in 25(OH)D levels proportional to the dose administered. In conclusion, a loading dose of 200,000 IU VTD3 followed by a monthly dose of 100,000 IU is the best dosing schedule to quickly and safely correct the VTD status.

SUBMITTER: Schleck ML

PROVIDER: S-EPMC4517004 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Randomized, Double-Blind, Parallel Study to Evaluate the Dose-Response of Three Different Vitamin D Treatment Schemes on the 25-Hydroxyvitamin D Serum Concentration in Patients with Vitamin D Deficiency.

Schleck Marie-Louise ML Souberbielle Jean-Claude JC Jandrain Bernard B Da Silva Stéphanie S De Niet Sophie S Vanderbist Francis F Scheen André A Cavalier Etienne E

Nutrients 20150703 7

Many people worldwide are vitamin D (VTD) deficient or insufficient, and there is still no consensus on the dose of VTD that should be administered to achieve a 25(OH)D concentration of 20 or 30 ng/mL. In this study, we aimed to determine an adapted supplementation of VTD able to quickly and safely increase the vitamin D status of healthy adults with low 25(OH)D. One hundred and fifty (150) subjects were randomized into three groups, each to receive, orally, a loading dose of 50,000, 100,000 or ...[more]

PMID: 26151178

Similar Datasets

Project description:BackgroundVitamin D is an essential micronutrient for the overall health and well-being of individuals. For strong musculoskeletal and neurological development of human body, vitamin D levels during childhood and adolescence have key importance. This is the first national-level study that analyzes the deficiency and concentration of serum 25-Hydroxyvitamin D [25(OH)D)] among Indian children and adolescents with respect to various demographic and socioeconomic characteristics.MethodsData of Comprehensive National Nutrition Survey (CNNS, 2016-18) was utilized for the present study. Vitamin D levels were assessed based on serum 25-hydroxyvitamin D concentration. Prevalence of vitamin D deficiency has been shown for the three age groups: 0-4 years (n = 12,764), 5-9 years (n = 13,482), 10-19 years (n = 13,065). Vitamin D deficiency was defined as: serum 25(OH)D < 12 ng/mL; and insufficiency as: 12 ng/ml ≤ 25(OH) < 20 ng/ml. 25(OH) D level higher than 20 ng/mL was accepted as adequate. Random slope multilevel logistic regression models were employed to assess the demographic and socioeconomic correlates of vitamin D deficiency.ResultsMean serum 25(OH)D concentration level was found to be 19.51 ± 8.76, 17.73 ± 7.91, and 17.07 ± 8.16 ng/ml in age group 0-4 years, 5-9 years and 10-19 years respectively. 49.12% of the children aged 0-4 years were having insufficient level of vitamin D. Prevalence of vitamin D deficiency was comparatively higher among female adolescents (76.16%), adolescents living in rural region (67.48), Sikh individuals (0-4 years: 76.28%; 5-9 years: 90.26%; 10-19 years: 89.56%), and adolescents coming from rich households. North-Indian individuals were having substantially higher odds of vitamin D deficiency in all the three age groups.ConclusionThe present study demonstrated that the prevalence of vitamin D deficiency is considerably high among children and adolescents of India. The study highlights high-risk group which require prompt policy interventions.

Project description:BackgroundIn the absence of dose-response data, Dietary Reference Values for vitamin D in nonpregnant adults are extended to pregnancy.ObjectiveThe aim was to estimate vitamin D intake needed to maintain maternal 25-hydroxyvitamin D [25(OH)D] in late gestation at a concentration sufficient to prevent newborn 25(OH)D <25-30 nmol/L, a threshold indicative of increased risk of nutritional rickets.DesignWe conducted a 3-arm, dose-response, double-blind, randomized placebo-controlled trial in Cork, Ireland (51.9oN). A total of 144 white-skinned pregnant women were assigned to receive 0, 10 (400 IU), or 20 (800 IU) µg vitamin D3/d from ≤18 wk of gestation. Vitamin D metabolites at 14, 24, and 36 wk of gestation and in cord sera, including 25(OH)D3, 3-epi-25(OH)D3, 24,25(OH)2D3, and 25(OH)D2 were quantified by liquid chromatography-tandem mass spectrometry. A curvilinear regression model predicted the total vitamin D intake (from diet and antenatal supplements plus treatment dose) that maintained maternal 25(OH)D in late gestation at a concentration sufficient to maintain cord 25(OH)D at ≥25-30 nmol/L.ResultsMean ± SD baseline 25(OH)D was 54.9 ± 10.7 nmol/L. Total vitamin D intakes at the study endpoint (36 wk of gestation) were 12.1 ± 8.0, 21.9 ± 5.3, and 33.7 ± 5.1 µg/d in the placebo and 10-µg and 20-µg vitamin D3 groups, respectively; and 25(OH)D was 24.3 ± 5.8 and 29.2 ± 5.6 nmol/L higher in the 10- and 20-µg groups, respectively, compared with placebo (P < 0.001). For maternal 25(OH)D concentrations ≥50 nmol/L, 95% of cord sera were ≥30 nmol/L and 99% were >25 nmol/L. The estimated vitamin D intake required to maintain serum 25(OH)D at ≥50 nmol/L in 97.5% of women was 28.9 µg/d.ConclusionsThirty micrograms of vitamin D per day safely maintained serum 25(OH)D concentrations at ≥50 nmol/L in almost all white-skinned women during pregnancy at a northern latitude, which kept 25(OH)D at >25 nmol/L in 99% and ≥30 nmol/L in 95% of umbilical cord sera. This trial was registered at www.clinicaltrials.gov as NCT02506439.

Dataset Information

A Randomized, Double-Blind, Parallel Study to Evaluate the Dose-Response of Three Different Vitamin D Treatment Schemes on the 25-Hydroxyvitamin D Serum Concentration in Patients with Vitamin D Deficiency.

Publications

A Randomized, Double-Blind, Parallel Study to Evaluate the Dose-Response of Three Different Vitamin D Treatment Schemes on the 25-Hydroxyvitamin D Serum Concentration in Patients with Vitamin D Deficiency.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets