High-dose Vitamin D safe for children (10,000 IU daily, 600,000 IU bolus) – meta-analysis

Safety of High-Dose Vitamin D Supplementation Among Children Aged 0 to 6 Years: A Systematic Review and Meta-analysis

AMA Netw Open. 2022 Apr 1;5(4):e227410 doi: 10.1001/jamanetworkopen.2022.7410.

Nicklas Brustad 1, Sina Yousef 1, Jakob Stokholm 1 2, Klaus Bønnelykke 1, Hans Bisgaard 1, Bo Lund Chawes 1

High- Dose Daily (<10,000 IU)

Bolus dose (<600,000 IU) note: Bolus taken over 1 - 60 days = Loading

Importance: Several health benefits of vitamin D have been suggested; however, the safety of high-dose supplementation in early childhood is not well described.

Objective: To systematically assess the risk of adverse events after high-dose supplementation with vitamin D reported in published randomized clinical trials.

Data sources: PubMed and ClinicalTrials.gov were searched through August 24, 2021.

Study selection: Randomized clinical trials of high-dose vitamin D supplementation in children aged 0 to 6 years, defined as greater than 1000 IU/d for infants (aged 0-1 year) and greater than 2000 IU/d for children aged 1 to 6 years.

Data extraction and synthesis: Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline, 2 reviewers independently extracted the data from the eligible studies. Summary risk ratio (RR), 95% CI, and P values were derived from random-effects meta-analysis.

Main outcomes and measures: Adverse events, serious adverse events (SAEs), and/or levels of 25-hydroxyvitamin D, calcium, alkaline phosphatase, phosphate, parathyroid hormone, and/or the ratio of urine calcium to creatinine levels.

Results: A total of 32 randomized clinical trials with 8400 unique participants were included. Different clinical outcomes of children receiving high-dose vitamin D supplements ranging from 1200 to 10 000 IU/d and bolus doses from 30 000 IU/week to a single dose of 600 000 IU were evaluated. Eight studies with 4612 participants were eligible for meta-analysis using a control group receiving either low-dose vitamin D supplementation (≤400 IU/d) or placebo when investigating the risk of SAEs such as hospitalization or death.

No overall increased risk of SAEs in the high-dose vitamin D vs control groups was found (RR, 1.01 [95% CI, 0.73-1.39]; P = .89, I2 = 0%).

In addition, risk of hypercalcemia (n = 726) was not increased (RR, 1.18 [95% CI, 0.72-1.93]; P = .51).

Clinical adverse events potentially related to the vitamin D supplementation reported in the studies were rare.

Conclusions and relevance: This meta-analysis and systematic review found that high-dose vitamin D supplementation was not associated with an increased risk of SAEs in children aged 0 to 6 years, and that clinical adverse events potentially related to the supplementation were rare. These findings suggest that vitamin D supplementation in the dose ranges of 1200 to 10 000 IU/d and bolus doses to 600 000 IU to young children may be well tolerated.

Summary clipped from PDF

"Thus, our findings suggest that vitamin D supplementation in the high-dose range of 1200 to 10 000 IU/d and bolus doses to 600 000 IU to infants and preschool children to 6 years of age may be safe in both healthy children and in children with various diseases."

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Vitamin D Life pages with HIGH-DOSE in title (63 as of April 2022 - all ages)

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Vitamin D Life - Loading Doses for Infants-Children are effective and safe ( studies)

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Vitamin D Life - Toxicity and Infants-Children ( studies)

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