Effect of weekly high-dose vitamin D3 supplementation on the association between circulatory FGF-23 and A1c levels in people with vitamin D deficiency: A randomized controlled 10-week follow-up trial
Main Article Content
Keywords
vitamin D deficiency, vitamin D3, fibroblast growth factor-23, A1c, OSC
Abstract
Purpose: This randomized clinical trial (RCT) was designed to assess the effect of vitamin D supplementation (VD3) on the relationship between the levels of fibroblast growth factor-23 (FGF-23) and osteocalcin factor (OSC) with glycated hemoglobin (A1c) values in the blood in a sample of Jordanian males and female adults with vitamin D deficiency. Subjects and methods: This RCT was designed to randomly split (78) eligible participants into two groups: experimental (Group A) and interventional (Group B). Group B was supplemented with a weekly dose of 50,000 IU VD3 for eight weeks. Fasting baseline and follow-up (10 weeks; 8 weeks supplementation plus washout two weeks) of serum 25 hydroxyvitamin D (25OHD), fibroblast growth factor-23, (FGF- 23), glycosylated hemoglobin (A1c), parathyroid hormone (PTH), calcium, and phosphorus were assayed. A paired T-test was used to assess the changes in fibroblast growth factor-23, A1c, and OSC levels over the follow-up period. RESULTS: Significant increase in follow-up level of 25OHD (40.04 ± 11.61 vs. 15.35 ± 5.41, PC < 0.001), FGF-23 (114.04 ± 103.8 vs. 87.40 ± 82.21, PA = 0.02) and A1c (5.63 ± 0.33 vs. 5.38 ± 0.32, PA = 0.01). Conclusion: High doses of vitamin D supplementation (50,000 IU/week) may have potentially negative effects on glycemic control, which might be related to changes in serum osteocalcin than in FGF23 levels.
References
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22. Kampmann U, Mosekilde L, Juhl C, et al. Effects of 12 weeks high dose vitamin D3 treatment on insulin sensitivity, beta cell function, and metabolic markers in patients with type 2 diabetes and vitamin D insufficiency–a double-blind, randomized, placebo-controlled trial. Metabolism. 2014;63(9):1115-1124. https://doi.org/10.1016/j.metabol.2014.06.008
23. Jackson RD, LaCroix AZ, Gass M, et al. Calcium plus vitamin D supplementation and the risk of fractures. New England Journal of Medicine. 2006;354(7):669-683. https://doi.org/10.1056/nejmoa055218
24. Holick MF, Binkley NC, Bischoff-Ferrari HA, et al. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. The Journal of clinical endocrinology & metabolism. 2011;96(7):1911-1930. https://doi. org/10.1210/jc.2011-0385
25. Binkley N, Gemar D, Engelke J, et al. Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults. The Journal of Clinical Endocrinology & Metabolism. 2011;96(4):981-988.
26. Wacker M, Holick MF. Sunlight and Vitamin D: A global perspective for health. Dermatoendocrinol. Jan 1 2013;5(1):51-108. https://doi.org/10.4161/derm.24494
27. Żebrowska A, Sadowska-Krępa E, Stanula A, et al. The effect of vitamin D supplementation on serum total 25 (OH) levels and biochemical markers of skeletal muscles in runners. Journal of the International Society of Sports Nutrition. 2020;17(1):18. https://doi.org/10.1186/s12970-020-00347-8
28. Mazahery H, Stonehouse W, Von Hurst P. The effect of monthly 50 000 IU or 100 000 IU vitamin D supplements on vitamin D status in premenopausal Middle Eastern women living in Auckland. European journal of clinical nutrition. 2015;69(3):367-372.
29. Turner C, Dalton N, Inaoui R, et al. Effect of a 300 000-IU loading dose of ergocalciferol (Vitamin D2) on circulating 1, 25 (OH) 2-vitamin D and fibroblast growth factor-23 (FGF-23) in vitamin D insufficiency. The Journal of Clinical Endocrinology & Metabolism. 2013;98(2):550-556. https://doi.org/10.1210/jc.2012-2790
30. Al Thani M, Sadoun E, Sofroniou A, et al. The effect of vitamin D supplementation on the glycemic control of pre-diabetic Qatari patients in a randomized control trial. BMC nutrition. 2019;5(1):1-10. https://doi.org/10.1186/s40795-019-0311-x
31. Lemieux P, Weisnagel SJ, Caron AZ, et al. Effects of 6-month vitamin D supplementation on insulin sensitivity and secretion: a randomised, placebo-controlled trial. European journal of endocrinology. 2019;181(3):287-299. https://doi.org/10.1530/ eje-19-0156
32. Jorde R, Grimnes G. Serum PTH is not a good marker for defining a threshold for vitamin D deficiency. Endocrine Connections. 2020;9(5):396-404. https://doi.org/10.1530/ec-20-0067
33. Byrne BE, Rooshenas L, Lambert HS, et al. A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and interpreted in practice. BMC Medical Research Methodology. 2020;20:1-12. https://doi. org/10.1186/s12874-020-01009-8
34. Li X, Liu Y, Zheng Y, et al. The effect of vitamin D supplementation on glycemic control in type 2 diabetes patients: a systematic review and meta-analysis. Nutrients. 2018;10(3):375. https://doi.org/10.3390/nu10030375
35. Mitchell DM, Leder BZ, Cagliero E, et al. Insulin secretion and sensitivity in healthy adults with low vitamin D are not affected by high-dose ergocalciferol administration: a randomized controlled trial. The American journal of clinical nutrition. 2015;102(2):385-392. https://doi.org/10.3945/ajcn.115.111682
36. Sherwani SI, Khan HA, Ekhzaimy A, et al. Significance of HbA1c test in diagnosis and prognosis of diabetic patients. Biomarker insights. 2016;11:BMI. S38440. https://doi.org/10.4137/bmi.s38440
37. El-Khateeb M, Khader Y, Batieha A, et al. Vitamin D deficiency and associated factors in Jordan. SAGE Open Medicine. 2019;7:2050312119876151. https://doi.org/10.1177/2050312119876151
38. Abu-Samak MS, AbuRuz ME, Masa’Deh R, et al. Correlation of selected stress associated factors with vitamin D deficiency in Jordanian men and women. International Journal of General Medicine. 2019:225-233. https://doi.org/10.2147/ijgm.s198175
39. Ghavam S, Ahmadi MRH, Panah AD, et al. Evaluation of HbA1C and serum levels of vitamin D in diabetic patients. Journal of family medicine and primary care. 2018;7(6):1314. https://doi.org/10.4103/jfmpc.jfmpc_73_18
40. Bilici ME, Erdeve S, Çetinkaya S, et al.The effect of 2000 ıu/day vitamin D supplementation on insulin resistance and cardiovascular risk parameters in vita min D deficient obese adolescents. Turk J Pediatr. 2019;61(5):723-32. https://doi. org/10.24953/turkjped.2019.05.011
41. Nada AM, Shaheen DA. Cholecalciferol improves glycemic control in type 2 diabetic patients: a 6-month prospective interventional study. Therapeutics and clinical risk management. 2017:813-820. https://doi.org/10.2147/tcrm.s132344
42. Burnett-Bowie S-AM, Leder BZ, Henao MP, et al. Randomized trial assessing the effects of ergocalciferol administration on circulating FGF23. Clinical journal of the American Society of Nephrology: CJASN. 2012;7(4):624. https://doi.org/10.2215/ cjn.10030911
43. Zittermann A, Berthold HK, Pilz S. The effect of vitamin D on fibroblast growth factor 23: a systematic review and meta-analysis of randomized controlled trials. European Journal of Clinical Nutrition. 2021;75(6):980-987. https://doi.org/10.1038/s41430- 020-00725-0
2. Mehdawi A, Mohammad BA, Mosleh I, et al. The combined effect of omega-3 fatty acid and vitamin D3 on oxidized LDL-C and non-HDL-C levels in people with vitamin D deficiency: A randomized controlled trial. Journal of Cardiovascular Pharmacology. 2022:10.1097. https://doi.org/10.1097/fjc.0000000000001398
3. Al-Shaer AH, Abu-Samak MS, Hasoun LZ, et al. Assessing the effect of omega-3 fatty acid combined with vitamin D3 versus vitamin D3 alone on estradiol levels: a randomized, placebo-controlled trial in females with vitamin D deficiency. Clinical Pharmacology: Advances and Applications. 2019:25-37. https://doi.org/10.2147/cpaa.s182927
4. Daboul SM, Abusamak M, Mohammad BA, et al. The effect of omega-3 supplements on the serum levels of ACE/ACE2 ratio as a potential key in cardiovascular disease: A randomized clinical trial in participants with vitamin D deficiency. Pharmacy Practice. 2023;21(1):1-9. https://doi.org/10.18549/pharmpract.2023.1.2761
5. Bader DA, Abed A, Mohammad BA, et al. The Effect of Weekly 50,000 IU Vitamin D3 Supplements on the Serum Levels of Selected Cytokines Involved in Cytokine Storm: A Randomized Clinical Trial in Adults with Vitamin D Deficiency. Nutrients. 2023;15(5):1188. https://doi.org/10.3390/nu15051188
6. Barham A, Mohammad B, Hasoun L, et al. The combination of omega− 3 fatty acids with high doses of vitamin D3 elevate A1c levels: A randomized Clinical Trial in people with vitamin D deficiency. International Journal of Clinical Practice. 2021;75(11):e14779. https://doi.org/10.1111/ijcp.14779
7. Awad SF, Huangfu P, Dargham SR, et al. Characterizing the type 2 diabetes mellitus epidemic in Jordan up to 2050. Scientific reports. 2020;10(1):21001. https://doi.org/10.1038/s41598-020-77970-7
8. Iqbal K, Islam N, Mehboobali N, et al. Association of vitamin D deficiency with poor glycaemic control in diabetic patients. J Pak Med Assoc. 2016;66(12):1562-1565.
9. Darraj H, Badedi M, Poore KR, et al. Vitamin D deficiency and glycemic control among patients with type 2 diabetes mellitus in Jazan City, Saudi Arabia. Diabetes, metabolic syndrome and obesity: targets and therapy. 2019:853-862. https://doi. org/10.2147/dmso.s203700
10. Pittas AG, Dawson-Hughes B, Sheehan P, et al. Vitamin D supplementation and prevention of type 2 diabetes. New England journal of medicine. 2019;381(6):520-530. https://doi.org/10.1056/nejmoa1900906
11. Scott D, Mousa A, Naderpoor N, et al. Vitamin D supplementation improves waist-to-hip ratio and fasting blood glucose in vitamin D deficient, overweight or obese Asians: a pilot secondary analysis of a randomised controlled trial. The Journal of Steroid Biochemistry and Molecular Biology. 2019;186:136-141. https://doi.org/10.1016/j.jsbmb.2018.10.006
12. Czech MP. Insulin action and resistance in obesity and type 2 diabetes. Nature medicine. 2017;23(7):804-814. https://doi. org/10.1038/nm.4350
13. de Oliveira LF, de Azevedo LG, da Mota Santana J, et al. Obesity and overweight decreases the effect of vitamin D supplementation in adults: systematic review and meta-analysis of randomized controlled trials. Reviews in Endocrine and Metabolic Disorders. 2020;21:67-76. https://doi.org/10.1007/s11154-019-09527-7
14. Álvarez-Rodríguez L, López-Hoyos M, Carrasco-Marín E, et al. Analysis of the rs20541 (R130Q) polymorphism in the IL-13 gene in patients with elderly-associated chronic inflammatory diseases. Reumatología Clínica (English Edition). 2012;8(6):321-327. https://doi.org/10.1016/j.reuma.2012.04.006
15. Bilotta FL, Arcidiacono B, Messineo S, et al. Insulin and osteocalcin: further evidence for a mutual cross-talk. Endocrine. 2018;59:622-632. https://doi.org/10.1007/s12020-017-1396-0
16. Van Driel M, Van Leeuwen JP. Vitamin D endocrine system and osteoblasts. BoneKEy Reports. 2014;3. https://doi.org/10.1038/ bonekey.2013.227
17. Zarei A, Morovat A, Javaid K, et al. Vitamin D receptor expression in human bone tissue and dose-dependent activation in resorbing osteoclasts. Bone research. 2016;4(1):1-10. https://doi.org/10.1038/boneres.2016.30
18. Zhang J, Liu J, Qin X. Advances in early biomarkers of diabetic nephropathy. Revista da Associacao Medica Brasileira. 2018;64:85- 92. https://doi.org/10.1590/1806-9282.64.01.85
19. Berezin AE, Berezin AA. Impaired function of fibroblast growth factor 23/Klotho protein axis in prediabetes and diabetes mellitus: Promising predictor of cardiovascular risk. Diabetes & Metabolic Syndrome: Clinical Research & Reviews. 2019;13(4):2549- 2556. https://doi.org/10.1016/j.dsx.2019.07.018
20. Balani S, Perwad F. Fibroblast growth factor 23 and phosphate homeostasis. Current opinion in nephrology and hypertension. 2019;28(5):465-473. https://doi.org/10.1097/mnh.0000000000000526
21. Gebreyohannes EA, Netere AK, Belachew SA. Glycemic control among diabetic patients in Ethiopia: a systematic review and meta-analysis. PLoS One. 2019;14(8):e0221790. https://doi.org/10.1371/journal.pone.0221790
22. Kampmann U, Mosekilde L, Juhl C, et al. Effects of 12 weeks high dose vitamin D3 treatment on insulin sensitivity, beta cell function, and metabolic markers in patients with type 2 diabetes and vitamin D insufficiency–a double-blind, randomized, placebo-controlled trial. Metabolism. 2014;63(9):1115-1124. https://doi.org/10.1016/j.metabol.2014.06.008
23. Jackson RD, LaCroix AZ, Gass M, et al. Calcium plus vitamin D supplementation and the risk of fractures. New England Journal of Medicine. 2006;354(7):669-683. https://doi.org/10.1056/nejmoa055218
24. Holick MF, Binkley NC, Bischoff-Ferrari HA, et al. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. The Journal of clinical endocrinology & metabolism. 2011;96(7):1911-1930. https://doi. org/10.1210/jc.2011-0385
25. Binkley N, Gemar D, Engelke J, et al. Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults. The Journal of Clinical Endocrinology & Metabolism. 2011;96(4):981-988.
26. Wacker M, Holick MF. Sunlight and Vitamin D: A global perspective for health. Dermatoendocrinol. Jan 1 2013;5(1):51-108. https://doi.org/10.4161/derm.24494
27. Żebrowska A, Sadowska-Krępa E, Stanula A, et al. The effect of vitamin D supplementation on serum total 25 (OH) levels and biochemical markers of skeletal muscles in runners. Journal of the International Society of Sports Nutrition. 2020;17(1):18. https://doi.org/10.1186/s12970-020-00347-8
28. Mazahery H, Stonehouse W, Von Hurst P. The effect of monthly 50 000 IU or 100 000 IU vitamin D supplements on vitamin D status in premenopausal Middle Eastern women living in Auckland. European journal of clinical nutrition. 2015;69(3):367-372.
29. Turner C, Dalton N, Inaoui R, et al. Effect of a 300 000-IU loading dose of ergocalciferol (Vitamin D2) on circulating 1, 25 (OH) 2-vitamin D and fibroblast growth factor-23 (FGF-23) in vitamin D insufficiency. The Journal of Clinical Endocrinology & Metabolism. 2013;98(2):550-556. https://doi.org/10.1210/jc.2012-2790
30. Al Thani M, Sadoun E, Sofroniou A, et al. The effect of vitamin D supplementation on the glycemic control of pre-diabetic Qatari patients in a randomized control trial. BMC nutrition. 2019;5(1):1-10. https://doi.org/10.1186/s40795-019-0311-x
31. Lemieux P, Weisnagel SJ, Caron AZ, et al. Effects of 6-month vitamin D supplementation on insulin sensitivity and secretion: a randomised, placebo-controlled trial. European journal of endocrinology. 2019;181(3):287-299. https://doi.org/10.1530/ eje-19-0156
32. Jorde R, Grimnes G. Serum PTH is not a good marker for defining a threshold for vitamin D deficiency. Endocrine Connections. 2020;9(5):396-404. https://doi.org/10.1530/ec-20-0067
33. Byrne BE, Rooshenas L, Lambert HS, et al. A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and interpreted in practice. BMC Medical Research Methodology. 2020;20:1-12. https://doi. org/10.1186/s12874-020-01009-8
34. Li X, Liu Y, Zheng Y, et al. The effect of vitamin D supplementation on glycemic control in type 2 diabetes patients: a systematic review and meta-analysis. Nutrients. 2018;10(3):375. https://doi.org/10.3390/nu10030375
35. Mitchell DM, Leder BZ, Cagliero E, et al. Insulin secretion and sensitivity in healthy adults with low vitamin D are not affected by high-dose ergocalciferol administration: a randomized controlled trial. The American journal of clinical nutrition. 2015;102(2):385-392. https://doi.org/10.3945/ajcn.115.111682
36. Sherwani SI, Khan HA, Ekhzaimy A, et al. Significance of HbA1c test in diagnosis and prognosis of diabetic patients. Biomarker insights. 2016;11:BMI. S38440. https://doi.org/10.4137/bmi.s38440
37. El-Khateeb M, Khader Y, Batieha A, et al. Vitamin D deficiency and associated factors in Jordan. SAGE Open Medicine. 2019;7:2050312119876151. https://doi.org/10.1177/2050312119876151
38. Abu-Samak MS, AbuRuz ME, Masa’Deh R, et al. Correlation of selected stress associated factors with vitamin D deficiency in Jordanian men and women. International Journal of General Medicine. 2019:225-233. https://doi.org/10.2147/ijgm.s198175
39. Ghavam S, Ahmadi MRH, Panah AD, et al. Evaluation of HbA1C and serum levels of vitamin D in diabetic patients. Journal of family medicine and primary care. 2018;7(6):1314. https://doi.org/10.4103/jfmpc.jfmpc_73_18
40. Bilici ME, Erdeve S, Çetinkaya S, et al.The effect of 2000 ıu/day vitamin D supplementation on insulin resistance and cardiovascular risk parameters in vita min D deficient obese adolescents. Turk J Pediatr. 2019;61(5):723-32. https://doi. org/10.24953/turkjped.2019.05.011
41. Nada AM, Shaheen DA. Cholecalciferol improves glycemic control in type 2 diabetic patients: a 6-month prospective interventional study. Therapeutics and clinical risk management. 2017:813-820. https://doi.org/10.2147/tcrm.s132344
42. Burnett-Bowie S-AM, Leder BZ, Henao MP, et al. Randomized trial assessing the effects of ergocalciferol administration on circulating FGF23. Clinical journal of the American Society of Nephrology: CJASN. 2012;7(4):624. https://doi.org/10.2215/ cjn.10030911
43. Zittermann A, Berthold HK, Pilz S. The effect of vitamin D on fibroblast growth factor 23: a systematic review and meta-analysis of randomized controlled trials. European Journal of Clinical Nutrition. 2021;75(6):980-987. https://doi.org/10.1038/s41430- 020-00725-0
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Effect of weekly high-dose vitamin D3 supplementation on the association between circulatory FGF-23 and A1c levels in people with vitamin D deficiency: A randomized controlled 10-week follow-up trial. Pharm Pract (Granada) [Internet]. 2024 May 31 [cited 2025 Jan. 14];22(2):1-8. Available from: https://www.pharmacypractice.org/index.php/pp/article/view/2934
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How to Cite
1.
Effect of weekly high-dose vitamin D3 supplementation on the association between circulatory FGF-23 and A1c levels in people with vitamin D deficiency: A randomized controlled 10-week follow-up trial. Pharm Pract (Granada) [Internet]. 2024 May 31 [cited 2025 Jan. 14];22(2):1-8. Available from: https://www.pharmacypractice.org/index.php/pp/article/view/2934