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A dose–response study of vitamin D3 supplementation in healthy Chinese: a 5-arm randomized, placebo-controlled trial

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Abstract

Purpose

To determine the dose–response of vitamin D3 supplementation on serum 25-hydroxyvitamin D [25(OH)D] among Chinese adults.

Methods

In this 5-arm, randomized, double-blinded controlled trial, 76 healthy participants were assigned to orally administrate 0, 400, 800, 1200 or 2000 IU/d of vitamin D3 for 16 weeks. Serum 25(OH)D, parathyroid hormone, calcium, biomarkers of liver and renal function were measured at multiple time points.

Results

The mean (SD) serum 25(OH)D at baseline was 31.6 (8.7) nmol/L, and the dose–response relationship was curvilinear with a plateau around 6 weeks for all doses. At week 16, 25(OH)D was increased by 6.0 (6.5), 21.7 (15.8), 26.3 (12.6), 32.0 (12.8) and 36.3 (26.0) nmol/L for 0, 400, 800, 1200 and 2000 IU/d (all P ≤ 0.002), corresponding to approximately 19, 53, 67, 77 and 80 % of reversion of vitamin D deficiency, respectively. Daily intake of 800 IU vitamin D3 reached a targeted 25(OH)D ≥ 30 nmol/L in at least 97.5 % of Chinese, but not a targeted 25(OH)D ≥ 50 nmol/L even with 2000 IU/d. Change of 25(OH)D was inversely associated with change of PTH concentration (r = −0.39, P < 0.001) after controlling for age and sex. No between-group differences were observed in terms of the change in serum calcium, alanine transaminase, aspartate aminotransferase, gamma-glutamyltransferase and creatinine (P ≥ 0.22).

Conclusions

Supplementation with 400, 800, 1200 or 2000 IU/d vitamin D could improve the vitamin D deficiency with various degrees. Whether 2000 IU/d vitamin D3 would generate a better result without side effect requires more studies with larger samples in future.

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Abbreviations

25(OH)D:

25-Hydroxyvitamin D

ALT:

Alanine transaminase

AST:

Aspartate aminotransferase

BMI:

Body mass index

DBP:

Diastolic blood pressure

GGT:

Gamma-glutamyltransferase

PTH:

Parathyroid hormone

SBP:

Systolic blood pressure

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Acknowledgments

This study was supported by Ministry of Science and Technology of China [2013BAI04B03], and the National Natural Science Foundation of China [81170734, 81321062]. The authors’ responsibilities were as follows: P. Y. and L. L., conducted research, performed statistical analysis and wrote the paper; Y. H., G. L., X. C., L. S., X. Y. and H. Z. conducted research; Y. C. and F. B. H contributed to data analysis and interpretation and edited the paper; H. L. and X. L. designed the study, conducted research and had primary responsibility for the final content. All authors reviewed and approved the final manuscript. We give our sincere thanks to Lixin Tang for the devotion during field work, Yiqing Song for advice during the manuscript preparation and especially to Dr. Walter Willett for his helpful comments. We further appreciate the strong support shown by Xiamen Xingsha Pharmaceutical Group Co., Ltd. Finally, the greatest thanks should be given to all the participants involved in this study.

Conflict of interest

The authors declare that there is no conflict of interest.

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Authors and Affiliations

  1. Key Laboratory of Nutrition and Metabolism, Institute for Nutritional Sciences, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences and Graduate University of the Chinese Academy of Sciences, 320 Yue-Yang Rd., Shanghai, 200031, China

    Pang Yao, Ling Lu, Yao Hu, Gang Liu, Liang Sun, Xingwang Ye, He Zheng, Yan Chen, Huaixing Li & Xu Lin

  2. Huadong Hospital, Fudan University, Shanghai, China

    Xiafei Chen

  3. Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA, USA

    Frank B. Hu

  4. State Key Laboratory of Genetic Engineering, Collaborative Innovation Center of Genetics and Development, Institute of Plant Biology, School of Life Sciences, Fudan University, Shanghai, China

    Xu Lin

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  1. Pang Yao
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Correspondence to Xu Lin.

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Pang Yao and Ling Lu have contributed equally to this article.

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Yao, P., Lu, L., Hu, Y. et al. A dose–response study of vitamin D3 supplementation in healthy Chinese: a 5-arm randomized, placebo-controlled trial. Eur J Nutr 55, 383–392 (2016). https://doi.org/10.1007/s00394-015-0859-4

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  • DOI: https://doi.org/10.1007/s00394-015-0859-4

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