Startseite Medizin Daily vs. monthly oral vitamin D3 for treatment of symptomatic vitamin D deficiency in infants: a randomized controlled trial
Artikel
Lizenziert
Nicht lizenziert Erfordert eine Authentifizierung

Daily vs. monthly oral vitamin D3 for treatment of symptomatic vitamin D deficiency in infants: a randomized controlled trial

  • Anupriya Gora , Preeti Singh , Ekta Debnath , Rajeev Kumar Malhotra und Anju Seth ORCID logo EMAIL logo
Veröffentlicht/Copyright: 18. Mai 2023

Abstract

Objectives

Compare the efficacy and safety of daily vs. monthly oral vitamin D3 in treating symptomatic vitamin D deficiency in infants.

Methods

90 infants with symptomatic vitamin D deficiency were randomized into Daily (D) [46 infants] and Bolus (B) [44 infants] groups to receive oral vitamin D3, daily (2000 IU/day) and bolus (60,000 IU/month) for three months respectively. Both groups received daily oral calcium @50 mg/kg/day. Serum calcium (Ca), phosphate (P), alkaline phosphatase (ALP), 25-hydroxy cholecalciferol [25(OH)D], parathyroid hormone (PTH) levels, urine calcium: creatinine ratio and radiological score were assessed at baseline, 4 and 12 weeks. At the end of 12 weeks, 78 infants were available for evaluation of efficacy and safety of both regimens.

Results

Both regimens led to a statistically significant increase in Ca and P levels and fall in ALP and PTH levels from baseline to 4 and 12 weeks of therapy, with no inter-group difference. Infants in group D had statistically significant higher mean 25(OH)D levels as compared to group B at 4 weeks (group D 130.89 ± 43.43 nmol/L, group B – 108.25 ± 32.40 nmol/L; p – 0.012) and 12 weeks (group D – 193.69 ± 32.47 nmol/L, group B – 153.85 ± 33.60 nmol/L; p<0.001). Eight infants [group D – 6/41 (14.6 %); group B – 2/37 (5.4 %), p=0.268] developed mild asymptomatic hypercalcemia without hypercalciuria at 12 weeks that corrected spontaneously within a week.

Conclusions

Both daily and monthly oral vitamin D3 in equivalent doses are efficacious and safe for treating symptomatic vitamin D deficiency in infants.


Corresponding author: Dr Anju Seth, Director Professor and Head, Department of Pediatrics, Lady Hardinge Medical College, New Delhi, India, Mobile: 9868206390, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: Cleared by the Institutional Ethics Committee, Lady Hardinge Medical College (LHMC/ECHR/2018/63 T) on 26/10/2018.

References

1. Creo, AL, Thacher, TD, Pettifor, JM, Strand, MA, Fischer, PR. Nutritional rickets around the world: an update. Paediatr Int Child Health 2017;37:84–98. https://doi.org/10.1080/20469047.2016.1248170.Suche in Google Scholar PubMed

2. Jiang, Z, Pu, R, Li, N, Chen, C, Li, J, Dai, W, et al.. High prevalence of vitamin D deficiency in Asia: a systematic review and meta-analysis. Crit Rev Food Sci Nutri 2021:1–10. https://doi.org/10.1080/10408398.2021.1990850.Suche in Google Scholar PubMed

3. Surve, S, Chauhan, S, Amdekar, Y, Joshi, B. Vitamin D deficiency in children: an update on its prevalence, therapeutics and knowledge gap s. Indian J Nutr 2017;4:167.Suche in Google Scholar

4. Mehrotra, P, Marwaha, RK, Aneja, S, Seth, A, Singla, BM, Ashraf, G, et al.. Hypovitaminosis d and hypocalcemic seizures in infancy. Indian Pediatr 2010;47:581–6. https://doi.org/10.1007/s13312-010-0131-1.Suche in Google Scholar PubMed

5. Maiya, S, Sullivan, I, Allgrove, J, Yates, R, Malone, M, Brain, C, et al.. Hypocalcaemia and vitamin D deficiency: an important, but preventable, cause of life-threatening infant heart failure. Heart 2008;94:581–4. https://doi.org/10.1136/hrt.2007.119792.Suche in Google Scholar PubMed

6. Munns, CF, Shaw, N, Kiely, M, Specker, BL, Thacher, TD, Ozono, K, et al.. Global consensus recommendations on prevention and management of nutritional rickets. J Clin Endocrinol Metab 2016;101:394–415. https://doi.org/10.1159/000443136.Suche in Google Scholar PubMed

7. Holick, MF, Binkley, NC, Bischoff-Ferrari, HA, Gordon, CM, Hanley, DA, Heaney, RP, Endocrine Society, et al.. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2011;96:1911–30. https://doi.org/10.1210/jc.2011-0385.Suche in Google Scholar PubMed

8. From Indian Academy of Pediatrics ‘Guideline for Vitamin D and Calcium in Children’ Committee, Khadilkar, A, Khadilkar, V, Chinnappa, J, Rathi, N, Khadgawat, R, Balasubramanian, S, et al.. Prevention and treatment of vitamin D and calcium deficiency in children and adolescents: Indian Academy of pediatrics (IAP) guidelines. Indian Pediatr. 2017;54:567–73. https://doi.org/10.1007/s13312-017-1070-x.Suche in Google Scholar PubMed

9. Gupta, P, Dabas, A, Seth, A, Bhatia, VL, Khadgawat, R, Kumar, P, et al.. Indian Academy of pediatrics revised (2021) guidelines on prevention and treatment of vitamin D deficiency and rickets. Indian Pediatr 2022;59:142–58. https://doi.org/10.1007/s13312-022-2448-y.Suche in Google Scholar

10. Tan, JK, Kearns, P, Martin, AC, Siafarikas, A. Randomised controlled trial of daily versus stoss vitamin D therapy in Aboriginal children. J Pediatr Child Health 2015;51:626–31. https://doi.org/10.1111/jpc.12781.Suche in Google Scholar PubMed

11. Emel, T, Doğan, DA, Erdem, G, Faruk, O. Therapy strategies in vitamin D deficiency with or without rickets: efficiency of low-dose stoss therapy. J Pediatr Endocrinol Metab 2012;25:107–10. https://doi.org/10.1515/jpem-2011-0368.Suche in Google Scholar PubMed

12. Tannous, P, Fiscaletti, M, Wood, N, Gunasekera, H, Zurynski, Y, Biggin, A, et al.. Safety and effectiveness of stoss therapy in children with vitamin D deficiency. J Paediatr Child Health 2020;56:81–9. https://doi.org/10.1111/jpc.14497.Suche in Google Scholar PubMed

13. Wadia, U, Soon, W, Chivers, P, Thambiran, A, Burgner, D, Cherian, S, et al.. Randomised controlled trial comparing daily versus depot vitamin D3 therapy in 0-16-year-old newly settled refugees in western Australia over a period of 40 weeks. Nutrients 2018;10:348. https://doi.org/10.3390/nu10030348.Suche in Google Scholar PubMed PubMed Central

14. Chow, SC, Shao, J, Wang, H, editors. Sample size calculations in clinical research, 2nd ed. USA: Chapman & Hall/CRC Biostatistics Series; 2008.Suche in Google Scholar

15. Kumar, N, Shekhar, C, Kumar, P, Kundu, AS. Kuppuswamy’s socioeconomic status scale––updated for 2007. Indian J Pediatr 2007;74:1131–2.Suche in Google Scholar

16. Thacher, TD, Fischer, PR, Pettifor, JM, Lawson, JO, Manaster, BJ, Reading, JC. Radiographic scoring method for the assessment of the severity of nutritional rickets. J Trop Pediatr 2000;46:132–9. https://doi.org/10.1093/tropej/46.3.132.Suche in Google Scholar PubMed

17. Lo, SF. Reference intervals for laboratory tests and procedures. In: Kleigman, RM, Behrman, RE, Jenson, HB, Stanton, BP, editors. Nelson text book of pediatrics, 20th ed. Philadelphia: Saunders Elsevier; 2011:3464–72 pp.Suche in Google Scholar

18. Balasubramanian, S. Vitamin D deficiency in breastfed infants & the need for routine vitamin D supplementation. Indian J Med Res 2011;133:250–2.Suche in Google Scholar

19. Najada, AS, Habashneh, MS, Khader, M. The frequency of nutritional rickets among hospitalized infants and its relation to respiratory diseases. J Trop Pediatr 2004;50:364–8. https://doi.org/10.1093/tropej/50.6.364.Suche in Google Scholar PubMed

20. Aggarwal, V, Seth, A, Marwaha, RK, Sharma, B, Sonkar, P, Singh, S, et al.. Management of nutritional rickets in Indian children: a randomized controlled trial. J Trop Pediatr 2013;59:127–33. https://doi.org/10.1093/tropej/fms058.Suche in Google Scholar PubMed

21. Saluja, RK, Dewan, P, Gomber, S, Madhu, SV, Bhat, S, Gupta, P. Low dose depot oral vitamin D3 v. daily oral vitamin D3 for treating nutritional rickets: a randomized clinical trial. Br J Nutr 2022;127:1778–83. https://doi.org/10.1017/S0007114521002713.Suche in Google Scholar PubMed

22. Talaat, IM, Kamal, NM, Alghamdi, HA, Alharthi, AA, Alshahrani, MA. A randomized clinical trial comparing three different replacement regimens of vitamin D in clinically asymptomatic pediatrics and adolescents with vitamin D insufficiency. Ital J Pediatr 2016;42:106. https://doi.org/10.1186/s13052-016-0314-z.Suche in Google Scholar PubMed PubMed Central

23. Hollis, BW, Wagner, CL. Clinical review: the role of the parent compound vitamin D with respect to metabolism and function: why clinical dose intervals can affect clinical outcomes. J Clin Endocrinol Metab 2013;98:4619–28. https://doi.org/10.1210/jc.2013-2653.Suche in Google Scholar PubMed PubMed Central

24. Vieth, R, Chan, PC, MacFarlane, GD. Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level. Am J Clin Nutr 2001;73:288–94. https://doi.org/10.1093/ajcn/73.2.288.Suche in Google Scholar PubMed

25. Gordon, CM, Williams, AL, Feldman, HA, May, J, Sinclair, L, Vasquez, A, et al.. Treatment of hypovitaminosis D in infants and toddlers. J Clin Endocrinol Metab 2008;93:2716–21. https://doi.org/10.1210/jc.2007-2790.Suche in Google Scholar PubMed PubMed Central

26. Pappa, HM, Mitchell, PD, Jiang, H, Kassiff, S, Filip-Dhima, R, DiFabio, D, et al.. Treatment of vitamin D insufficiency in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing three regimens. J Clin Endocrinol Metab 2012;97:2134–42. https://doi.org/10.1210/jc.2011-3182.Suche in Google Scholar PubMed PubMed Central

27. Mittal, M, Yadav, V, Khadgawat, R, Kumar, M, Sherwani, P. Efficacy and safety of 90,000 IU versus 300,000 IU single dose oral vitamin D in nutritional rickets: a randomized controlled trial. Indian J Endocrinol Metab 2018;22:760–5. https://doi.org/10.4103/ijem.ijem_84_18.Suche in Google Scholar PubMed PubMed Central

28. Mittal, H, Rai, S, Shah, D, Madhu, SV, Mehrotra, G, Malhotra, RK, et al.. 300,000 IU or 600,000 IU of oral vitamin D3 for treatment of nutritional rickets: a randomized controlled trial. Indian Pediatr 2014;51:265–72. https://doi.org/10.1007/s13312-014-0399-7.Suche in Google Scholar PubMed

29. Harnot, J, Verma, S, Singhi, S, Sankhyan, N, Sachdeva, N, Bharti, B. Comparison of 300,000 and 600,000 IU oral vitamin-D bolus for vitamin-D deficiency in young children. Indian J Pediatr 2017;84:111–6. https://doi.org/10.1007/s12098-016-2233-9.Suche in Google Scholar PubMed

30. Shakiba, M, Sadr, S, Nefei, Z, Mozaffari-Khosravi, H, Lotfi, MH, Bemanian, MH. Combination of bolus dose vitamin D with routine vaccination in infants: a randomized trial. Singapore Med J 2010;51:440–5.Suche in Google Scholar

31. Shakiba, M, Pahloosye, A, Mirouliaei, M, Islami, Z. Comparison of two regimens of vitamin D supplementation for vitamin D-deficient neonate s. Singapore Med J 2014;55:266–70. https://doi.org/10.11622/smedj.2014070.Suche in Google Scholar PubMed PubMed Central

32. Huynh, J, Lu, T, Liew, D, Doery, JC, Tudball, R, Jona, M, et al.. Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants. J Paediatr Child Health 2017;53:163–9. https://doi.org/10.1111/jpc.13338.Suche in Google Scholar PubMed

33. Lewis, RD, Laing, EM, Hill Gallant, KM, Hall, DB, McCabe, GP, Hausman, DB, et al.. A randomized trial of vitamin D₃ supplementation in children: dose-response effects on vitamin D metabolites and calcium absorption. J Clin Endocrinol Metab 2013;98:4816–25. https://doi.org/10.1210/jc.2013-2728.Suche in Google Scholar PubMed PubMed Central

34. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Scientific opinion on the tolerable upper intake level of vitamin D. EFSA J 2012;10:45.10.2903/j.efsa.2012.2813Suche in Google Scholar

35. Zittermann, A, Pilz, S, Berthold, HK. Serum 25-hydroxyvitamin D response to vitamin D supplementation in infants: a systematic review and meta-analysis of clinical intervention trials. Eur J Nutr 2020;59:359–69. https://doi.org/10.1007/s00394-019-01912-x.Suche in Google Scholar PubMed

36. McKenna, MJ, Murray, BF. Vitamin D dose response is underestimated by endocrine society’s clinical practice guideline. Endocr Connect 2013;2:87–95. https://doi.org/10.1530/ec-13-0008.Suche in Google Scholar

Received: 2023-01-09
Accepted: 2023-04-19
Published Online: 2023-05-18
Published in Print: 2023-07-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

Artikel in diesem Heft

  1. Frontmatter
  2. Review Article
  3. Molecular mechanisms involved in fetal programming and disease origin in adulthood
  4. Original Articles
  5. Neuropathy in paediatric type 1 diabetes mellitus – clinical characterization and analysis of risk factors in the diabetes prospective follow-up registry DPV (Diabetes-Patienten-Verlaufsdokumentation)-registry
  6. Effect of metabolic control on cognitive functions in children and adolescents with type 1 diabetes mellitus
  7. Uric acid and sCD163 as biomarkers for metabolic dysfunction and MAFLD in children and adolescents with overweight and obesity
  8. Endocrinological, immunological and metabolic features of patients with Fabry disease under therapy
  9. Evaluation and management of pediatric thyroid nodules and thyroid cancer at a single institution after adoption of the American Thyroid Association 2015 guidelines
  10. Fasting ketone levels vary by age: implications for differentiating physiologic from pathologic ketotic hypoglycemia
  11. Association of adipocytokines and adipocytokine ratios with cardiovascular risk factors in Japanese preadolescents
  12. Daily vs. monthly oral vitamin D3 for treatment of symptomatic vitamin D deficiency in infants: a randomized controlled trial
  13. Short Communication
  14. Management and outcomes in secondary diabetes among pediatric patients hospitalized with hemophagocytic lymphohistiocytosis
  15. Letter to the Editor
  16. Potential usefulness of assessing serum betamethasone levels during betamethasone therapy
  17. Case Reports
  18. Acquired idiopathic isolated ACTH deficiency with associated autoimmune thyroiditis in pediatrics: case report and review of the literature
  19. A very rare cause of hypertrygliseridemia in infancy: a novel mutation in glycerol-3-phosphate dehydrogenase 1 (GPD1) gene
  20. Difficult to think about but easy to treat: scurvy
  21. Severe hypophosphataemia can be an early sign of osteopetrorickets: a case report
  22. Corrigendum
  23. Diagnosis of adrenal insufficiency in children: a survey among pediatric endocrinologists in North America
Heruntergeladen am 8.1.2026 von https://www.degruyterbrill.com/document/doi/10.1515/jpem-2023-0146/pdf
Button zum nach oben scrollen