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A dose-response study of vitamin D3 supplementation in healthy Chinese: a 5-arm randomized, placebo-controlled trial.
Eur J Nutr. 2016 Feb; 55(1):383-92.EJ

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.

Authors+Show Affiliations

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.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.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.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.Huadong Hospital, Fudan University, Shanghai, China.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.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.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.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.Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA, USA.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.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. xlin@sibs.ac.cn. 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. xlin@sibs.ac.cn.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25694350

Citation

Yao, Pang, et al. "A Dose-response Study of Vitamin D3 Supplementation in Healthy Chinese: a 5-arm Randomized, Placebo-controlled Trial." European Journal of Nutrition, vol. 55, no. 1, 2016, pp. 383-92.
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. 2016;55(1):383-92.
Yao, P., Lu, L., Hu, Y., Liu, G., Chen, X., Sun, L., Ye, X., Zheng, H., Chen, Y., Hu, F. B., Li, H., & Lin, X. (2016). A dose-response study of vitamin D3 supplementation in healthy Chinese: a 5-arm randomized, placebo-controlled trial. European Journal of Nutrition, 55(1), 383-92. https://doi.org/10.1007/s00394-015-0859-4
Yao P, et al. A Dose-response Study of Vitamin D3 Supplementation in Healthy Chinese: a 5-arm Randomized, Placebo-controlled Trial. Eur J Nutr. 2016;55(1):383-92. PubMed PMID: 25694350.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A dose-response study of vitamin D3 supplementation in healthy Chinese: a 5-arm randomized, placebo-controlled trial. AU - Yao,Pang, AU - Lu,Ling, AU - Hu,Yao, AU - Liu,Gang, AU - Chen,Xiafei, AU - Sun,Liang, AU - Ye,Xingwang, AU - Zheng,He, AU - Chen,Yan, AU - Hu,Frank B, AU - Li,Huaixing, AU - Lin,Xu, Y1 - 2015/02/19/ PY - 2014/10/10/received PY - 2015/02/05/accepted PY - 2015/2/20/entrez PY - 2015/2/20/pubmed PY - 2016/11/9/medline KW - Dose–response KW - Safety KW - Serum 25-hydroxyvitamin D KW - Vitamin D3 supplementation SP - 383 EP - 92 JF - European journal of nutrition JO - Eur J Nutr VL - 55 IS - 1 N2 - 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. SN - 1436-6215 UR - https://www.unboundmedicine.com/medline/citation/25694350/A_dose_response_study_of_vitamin_D3_supplementation_in_healthy_Chinese:_a_5_arm_randomized_placebo_controlled_trial_ L2 - https://dx.doi.org/10.1007/s00394-015-0859-4 DB - PRIME DP - Unbound Medicine ER -