Efficacy and Tolerability of a High Loading Dose (25,000 IU Weekly) Vitamin D&lt;sub&gt;3&lt;/sub&gt; Supplementation in Obese Children with Vitamin D Insufficiency/Deficiency

Radhakishun, Nalini N. E.; Vliet, Mariska van; Poland, Dennis C W; Weijer, Olivier; Beijnen, Jos H.; Brandjes, Dees P. M.; Diamant, Michaëla; Rosenstiel, Inès A. von

doi:10.1159/000362236

Cited by 10 publications

(6 citation statements)

References 11 publications

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“…Prior to our study, there was no consensus on the recommended dose of vitamin D to achieve sufficiency in children and adolescents with overweight/obesity, nor whether the high doses of vitamin D that may be required to achieve an ideal 25(OH)D level would do so at the cost of toxicity. Previous studies in children and adolescents with overweight/obesity have demonstrated that higher loading doses of oral vitamin D may be indicated in children and adolescents with higher body fat given their lower rise in serum vitamin D levels compared with children and adolescents with a normal BMI, consistent with our PK analysis in this study showing that doses much higher than standard of care are needed for children and adolescents with overweight/obesity and asthma 19,20 . The prevalence of vitamin D deficiency in children with overweight/obesity in the United States varies based on geographic location, time of year, skin color, and the definition of vitamin D deficiency utilized 18 .…”

Section: Discussionsupporting

confidence: 87%

Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial

O'Sullivan,

Ounpraseuth,

James

et al. 2023

Clin Pharma and Therapeutics

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Children with asthma and obesity are more likely to have lower vitamin D levels, but the optimal replacement dose is unknown in this population. The objective of this study is identifying a vitamin D dose in children with obesity‐related asthma that safely achieves serum vitamin D levels of ≥ 40 ng/mL. This prospective multisite randomized controlled trial recruited children/adolescents with asthma and body mass index ≥ 85% for age/sex. Part 1 (dose finding), evaluated 4 oral vitamin D regimens for 16 weeks to identify a replacement dose that achieved serum vitamin D levels ≥ 40 ng/mL. Part 2 compared the replacement dose calculated from part 1 (50,000 IU loading dose with 8,000 IU daily) to standard of care (SOC) for 16 weeks to identify the proportion of children achieving target serum 25(OH)D level. Part 1 included 48 randomized participants. Part 2 included 64 participants. In Part 1, no SOC participants achieved target serum level, but 50–72.7% of participants in cohorts A‐C achieved the target serum level. In part 2, 78.6% of replacement dose participants achieved target serum level compared with none in the SOC arm. No related serious adverse events were reported. This trial confirmed a 50,000 IU loading dose plus 8,000 IU daily oral vitamin D as safe and effective in increasing serum 25(OH)D levels in children/adolescents with overweight/obesity to levels ≥ 40 ng/mL. Given the critical role of vitamin D in many conditions complicating childhood obesity, these data close a critical gap in our understanding of vitamin D dosing in children.

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Section: Discussionsupporting

confidence: 87%

Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial

O'Sullivan,

Ounpraseuth,

James

et al. 2023

Clin Pharma and Therapeutics

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“…The current evidence does not support vitamin D supplementation as monotherapy for children with ASD. However, it seems feasible that vitamin D might be used to complement other treatments for ASD considering its long-term tolerability and acceptability 42,43 , its critical role in brain function and development, and its roles in various metabolic pathways involved in the pathobiology of ASD 38 . It will be important to employ one uniform assessment tool in order to reduce methodological bias.…”

Section: Discussionmentioning

confidence: 99%

The effect of vitamin D supplementation in treatment of children with autism spectrum disorder: a systematic review and meta-analysis of randomized controlled trials

Zhang

et al. 2020

Nutritional Neuroscience

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Objective: The effect of vitamin D supplementation on the risk of Autism Spectrum Disorder (ASD) is conflicting. The aim of this study was to estimate the efficacy of vitamin D supplementation on ASD in children. Methods: We conducted a meta-analysis of randomized controlled trials (RCTs) in which vitamin D supplementation was used as a therapy in children with ASD. The PubMed, PsychINFO, Cochrane CENTRAL library, Web of Science, and Cinahl databases were searched from inception to March 20, 2019, for all publications on vitamin D and ASD with no restrictions. Studies involving individuals aged <18 years diagnosed with ASD and with all functional outcomes assessed by measurement scales for ASD were included. Mean differences were pooled, and a meta-analysis was performed using a random-effects model due to differences between the individual RCTs. Results: There were five RCTs with 349 children with ASD in the review, of which three RCTs were included in the meta-analysis. Vitamin D supplementation indicated a small but significant improvement in hyperactivity scores (pooled MD: −3.20; 95% CI: [−6.06, −0.34]) with low heterogeneity (I 2 = 10%, p = 0.33), but there were no other statistically significant differences in ASD symptoms between groups as measured by validated scales. Conclusion: Vitamin D supplementation appears to be beneficial for hyperactivity but not for core symptoms or other co-existing behaviors and conditions of ASD. Future RCTs with large sample sizes examining the effect of vitamin D supplementation on ASD among individuals with low serum vitamin D levels at baseline are needed.

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“…Recommendation of Endocrine Society guidelines suggested with 50,000 IU once a week for 8 weeks or 6000 IU/ day of vitamin D3 to achieve a serum concentration of 25 (OH)D3 > 30 ng/mL, followed by maintenance therapy of 1500-2000 IU/day [44]. A vitamin D supplementation with 25,000 IU weekly in young people with obesity (8-18-year olds) was found to be well tolerated and restored a sufficient vitamin D status in more than 84% of individuals [116].…”

Section: Vitamin D Treatmentmentioning

confidence: 97%

Obesity and hypovitaminosis D: causality or casualty?

et al. 2019

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Epidemiological studies reported that vitamin D deficiency represents an increasingly widespread phenomenon in various populations. Vitamin D deficiency is considered a clinical syndrome determined by low circulating levels of 25hydroxyvitamin D (25(OH)D), which is the biologically-inactive intermediate and represents the predominant circulating form. Different mechanisms have been hypothesized to explain the association between hypovitaminosis D and obesity, including lower dietary intake of vitamin D, lesser skin exposure to sunlight, due to less outdoor physical activity, decreased intestinal absorption, impaired hydroxylation in adipose tissue and 25(OH)D accumulation in fat. However, several studies speculated that vitamin D deficiency itself could cause obesity or prevent weight loss. The fat-solubility of vitamin D leads to the hypothesis that a sequestration process occurs in body fat depots, resulting in a lower bioavailability in the obese state. After investigating the clinical aspects of vitamin D deficiency and the proposed mechanisms for low 25 (OH)D in obesity, in this manuscript we discuss the possible role of vitamin D replacement treatment, with different formulations, to restore normal levels in individuals affected by obesity, and evaluate potential positive effects on obesity itself and its metabolic consequences. Food-based prevention strategies for enhancement of vitamin D status and, therefore, lowering skeletal and extra-skeletal diseases risk have been widely proposed in the past decades; however pharmacological supplementation, namely cholecalciferol and calcifediol, is required in the treatment of vitamin D insufficiency and its comorbidities. In individuals affected by obesity, high doses of vitamin D are required to normalize serum vitamin D levels, but the different liposolubility of different supplements should be taken into account. Although the results are inconsistent, some studies reported that vitamin D supplementation may have some beneficial effects in people with obesity.

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Efficacy and Tolerability of a High Loading Dose (25,000 IU Weekly) Vitamin D<sub>3</sub> Supplementation in Obese Children with Vitamin D Insufficiency/Deficiency

Cited by 10 publications

References 11 publications

Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial

Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial

The effect of vitamin D supplementation in treatment of children with autism spectrum disorder: a systematic review and meta-analysis of randomized controlled trials

Obesity and hypovitaminosis D: causality or casualty?

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