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Assessment of the effect of routine-dose vitamin D3 supplementation in Chinese women of childbearing age with vitamin D insufficiency.

  • 2025-05-30
  • European journal of nutrition 64(5)
    • Xiaoyun Shan
    • Wenxuan Wu
    • Jingxin Yang
    • Yang Cao
    • Yuting Li
    • Yichun Hu
    • Rui Wang
    • Lichen Yang

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 44
Population
women of childbearing age (18-50 years) with vitamin D insufficiency [serum total 25(OH)D < 20 ng/mL]
Methods
Single-group repeated measures design; 26-week trial of oral vitamin D3 supplementation at 400 IU/day (n=15) and 800 IU/day (n=25) with a parallel observation group (n=5)
Blinding
Open-label
Duration
26 weeks
Funding
Unclear
  • Rigorous Journal

Background

It was reported that vitamin D deficiency is common in Chinese women of childbearing age. Although most government dietary guidelines recommend routine-dose (400-800 IU/d), the evidence from intervention studies using routine-dose is quite limited.

Objective

In this study, the effects of daily supplementation with routine-dose of vitamin D3 in women of childbearing age with vitamin D insufficiency on vitamin D nutritional status and bone metabolism markers were assessed by dynamic tracking, and the thresholds for appropriate levels of vitamin D in this population was also explored.

Methods

Single-group repeated measures design was performed. Forty-five women of childbearing age (18-50 years) with vitamin D insufficiency [serum total 25(OH)D < 20 ng/mL] were recruited. A 26-week trial of oral vitamin D3 supplementation at 400 international units (IU)/day (n = 15) and 800 IU/day (n = 25) was conducted for subjects in the intervention group with a parallel observation group (n = 5). Trends in serum total 25(OH)D and parathyroid hormone (PTH) were observed at baseline, 2, 3, 4, 5, 6, 10, 12, 14, 16, and 26 weeks, while free and bioavailable 25(OH)D and bone turnover markers (BTMs) were dynamically tracked. The intervention effect was then further analyzed by subgroup including 400 IU/d + low PTH group (n = 7), 400 IU/d + high PTH group (n = 8), 800 IU/d + low PTH group (n = 12), and 800 IU/d + high PTH group (n = 13) based on baseline serum PTH concentration. The appropriate level of total 25(OH)D was defined as the thresholds at which serum PTH can be maximally suppressed or plateaued and was explored by polynomial comparison and Gaussian process regression.

Results

A total of 44 out of 45 (97.8%) participants completed the intervention and follow-up. By dynamic tracking, serum total 25(OH)D increased rapidly in women of childbearing age with vitamin D insufficiency after supplementation both with 400 IU/d and 800 IU/d of vitamin D3 during the first 4 weeks. Serum vitamin D status improved greatly after 26 weeks, with significant increases in total 25(OH)D, free 25(OH)D and bioavailable 25(OH)D concentrations compared with baseline. There was no statistically significant difference in the effect of the intervention between the two dose groups. Serum PTH decreased during the first 6 weeks, after which it entered a plateau, especially in the group with higher baseline serum PTH. While BTMs were relatively stable. The range of thresholds obtained by polynomial comparison and Gaussian process regression were 20.24-23.95 ng/mL and 20.2-21.65 ng/mL, respectively.

Conclusion

Routine-dose of vitamin D3 supplementation was proved to be, an effective and compliant supplementation approach in women of childbearing age with vitamin D insufficiency. The average of the total 25(OH)D threshold predicted by Gaussian process regression for the high PTH groups was approximately 21 ng/mL, which could be recommended as the reference level for appropriate vitamin D in Chinese women of childbearing age. This trial was registered with the Chinese clinical trial registry as ChiCTR2200058290.

Clinical trial registration

ChiCTR2200058290. https://www.chictr.org.cn/showprojEN.html?proj=162610.

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