Skip to main content

Advertisement

SpringerLink
Log in

Comparison of 300,000 and 600,000 IU Oral Vitamin-D Bolus for Vitamin-D Deficiency in Young Children

  • Original Article
  • Published:
The Indian Journal of Pediatrics Aims and scope Submit manuscript

Abstract

Objective

To compare the efficacy and safety of 300,000 and 600,000 IU vitamin-D single-oral dose for the treatment of vitamin-D deficiency (VDD) in young children (3 mo – 3 y).

Methods

This double-blind randomized control trial (Clinical Trail Registration-CTRI/2012/05/002621) was conducted in the Pediatric out-patient department (OPD) at a tertiary-care referral hospital. Children (3 mo – 3 y) with clinical/radiological features suggestive of VDD were screened; those found to be having 25(OH)D below 15 ng/ml and meeting inclusion and exclusion criteria’s were enrolled after taking informed consent. They were randomized into two groups, one receiving 600,000 and other 300,000 IU vitamin-D orally stat (Stoss-therapy). Primary outcome measure was proportion of children developing hypercalcemia/and hypercalciuria at day 7–10 post-therapy. Secondary outcome measures were proportion of children with hypercalciuria at day 3–5, hypercalcemia/and hypercalciuria at day 25–30 and 25(OH)D sufficiency at day 25–30 post-therapy.

Results

Sixty children, 30 in each group were randomized to two study groups. Baseline variables were comparable in two groups. Primary outcome measure (proportion of children with hypercalcemia/and hypercalciuria at 7 – 10th d) were 18.5 % (5/27) in 600,000 and 10.7 % (3/28) in 300,000 IU group (P = 0.47). Secondary outcome measures were - i) Proportion of children with hypercalciuria (3–5th d) were 18.5 % (5/27) in 600,000 and 7 % (2/28) in 300,000 group (P = 0.25). ii) Proportion of children with hypercalcemia/and hypercalciuria (25–30th d) were 18.5 % (5/27) in 600,000 and 11 % (3/28) in 300,000 group (P = 0.47). iii) All children in both groups had 25(OH)D levels in sufficiency range (25–30th d). With this sample size no significant difference in any of the group could be established.

Conclusions

The superiority of 300,000 over 600,000 IU vitamin-D single-dose oral therapy for VDD in children (3 mo – 3 y) in terms of safety could not be established with this sample size, although the prevalence of hypercalcemia/and hypercalciuria was observed more with 600,000 IU group. Both the regimens were effective for treating VDD at 25–30th d post-therapy.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Abbreviations

VDD:

Vitamin D deficiency

IU:

International unit

CTRI:

Central trial registry of India

ICMR:

Indian council of medical research

OPD:

Out patient department

Ca:

Calcium

P:

Phosphorus

ALP:

Alkaline phosphatase

25OHD:

25-hydroxy vitamin D

Ca/Cr:

Calcium creatinine ratio

ng/ml:

Nanogram per milliliter

mg/dl:

Milligram per deciliter

L:

Lakh

RR:

Relative risk

CI:

Confidence interval

IM:

Intramuscular

p.o.:

per orally

References

  1. Babu US, Calvo MS. Modern India and the vitamin D dilemma: evidence for the need of a national food fortification program. Mol Nutr Food Res. 2010;54:1134–47.

    CAS  PubMed  Google Scholar 

  2. Balasubramanian K, Rajeswari J, Govil YC, Agarwal AK, Kumar A, Bhatia V. Varying role of vitamin D deficiency in the etiology of rickets in young children. J Trop Pediatr. 2003;49:201–6.

    Article  CAS  PubMed  Google Scholar 

  3. Mithal A, Wahl DA, Bonjour JP, et al. Global vitamin D status and determinants of hypovitaminosis D. Osteoporos Int. 2009;20:1807–20.

    Article  CAS  PubMed  Google Scholar 

  4. Verma S, Khadwal A, Chopra K, Rohit M, Singhi S. Hypocalcemic nutritional rickets: a treatable cause of dilated cardiomyopathy. J Trop Pediatr. 2011;57:126–8.

    Article  PubMed  Google Scholar 

  5. Heird WC. Vitamin deficiencies and excesses. In: Behrman ER, Kliegman MR, Jenson BH, editors. Nelson Textbook of Pediatrics. 17th ed. Philadelphia: WB Saunders Co; 2004. p. 177–90.

    Google Scholar 

  6. Gertner JM. Metabolic bone disease. In: Lifshitz F, editor. Pediatric Endocrinology. 4th ed. New York: Marcel Dekker, Inc; 2003. p. 517–39.

    Google Scholar 

  7. Mimouni F. Single day therapy for rickets. J Pediatr. 1995;126:1019–20.

    Article  CAS  PubMed  Google Scholar 

  8. Davies M. High-dose vitamin D therapy: indications, benefits and hazards. Int J Vitam Nutr Res Suppl. 1989;30:81–6.

    CAS  PubMed  Google Scholar 

  9. Vogiatzi MG, Jacobson-Dickman E, DeBoer MD; Drugs, and therapeutics Committee of the Pediatric Endocrine Society. Vitamin D supplementation and risk of toxicity in pediatrics: a review of current literature. J Clin Endocrinol Metab. 2014;99:1132–41.

  10. Cesur Y, Caksen H, Gundem A, Kirimi E, Odabas D. Comparision of low and high dose of vitamin D treatment in nutritional vitamin D deficiency rickets. J Pediatr Endocrinol Metab. 2003;16:1105–9.

    Article  CAS  PubMed  Google Scholar 

  11. Joshi R. Hypercalcemia due to hypervitaminosis D: report of seven patients. J Trop Pediatr. 2009;55:396–8.

    Article  PubMed  Google Scholar 

  12. Dayal D, Didel SR, Agarwal S, Sachdeva N, Singh M. Acute hypercalcaemia and hypervitaminosis D in an infant with extra pulmonary tuberculosis. J Clin Diagn Res. 2015;9:SD03–4.

    CAS  PubMed  PubMed Central  Google Scholar 

  13. Ross AC, Manson JE, Abrams SA, et al. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011;96:53–8.

    Article  CAS  PubMed  Google Scholar 

  14. Ozkan B, Hatun S, Bereket A. Vitamin D intoxication. Turk J Pediatr. 2012;54:93–8.

  15. Sargent JD, Stukel TA, Kreseel J, Klein RZ. Normal values for random urinary calcium to creatinine ratios in infancy. J Pediatr. 1993;123:393–7.

    Article  CAS  PubMed  Google Scholar 

  16. Mittal H, Rai S, Shad D, 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.

    Article  PubMed  Google Scholar 

  17. Rathi N, Rathi A. Vitamin D and child health in the twenty-first century. Indian Pediatr. 2011;48:619–25.

  18. Holick MF, Garabedian M. Vitamin D: photobiology, metabolism, mechanism of action, and clinical applications. In: Favus MJ, editor. Primer on the metabolic bone disease and disorders of mineral metabolism. 6th ed. Washington, DC: American Society for Bone and Mineral Research; 2006. p. 129–37.

    Google Scholar 

  19. Misra M, Pacaud D, Petryk A, Collett-Solberg PF, Kappy M; Drug and Therapeutics Committee of the Lawson Wilkins Pediatric Endocrine Society. Vitamin D deficiency in children and its management: review of current knowledge and recommendations. Pediatrics. 2008;122:398–417.

  20. Stogmann W, Sacher M, Blumel P, Woloszczuk W. Vitamin D deficiency rickets: single-dose therapy versus continous therapy. Padiatr Padol. 1985;20:385–92.

    CAS  PubMed  Google Scholar 

  21. Gordon CM, Williams AL, Feldman HA, et al. Treatment of hypovitaminosis D in infants and toddlers. J Clin Endocrinol Metab. 2008;93:2716–21.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. Shah B, Finberg L. Single day therapy for nutritional vitamin D deficiency rickets: a preferred method. J Pediatr. 1994;125:487–90.

    Article  CAS  PubMed  Google Scholar 

  23. Balasubramanian S, Dhanalakshmi K, Amperayani S. Vitamin D deficiency in childhood- a review of current guidelines on diagnosis and management. Indian Pediatr. 2013;50:669–75.

    Article  CAS  PubMed  Google Scholar 

  24. Akcam M, Yildiz M, Yilmaz A, Artan R. Bone mineral density in response to two different regimen in rickets. Indian Pediatr. 2006;43:423–7.

    PubMed  Google Scholar 

  25. Munns CF, Shaw N, Kiely M, et al. Global consensus recommendations on prevention and management of nutritional rickets. J Clin Endocrinol Metab. 2016;101:394–415.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Contributions

JL was involved in conceptualization, developing protocol, collecting data, patient management, reviewing literature and drafting manuscript; SV was involved in conceptualization, developing protocol, reviewing literature and drafting manuscript; SS was involved in conceptualization, developing protocol and editing final manuscript; NS was involved in conceptualization, developing protocol, monitoring protocol, reviewing literature and drafting manuscript; NarS provided the laboratory support for detailed investigation of cases and was involved in drafting manuscript; BB was involved in management of cases, reviewing literature and drafting the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. SV will act as guarantor for the paper.

Author information

Authors and Affiliations

  1. Department of Pediatrics, Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India

    Jiyalal Harnot, Sanjay Verma, Sunit Singhi, Naveen Sankhyan & Bhavneet Bharti

  2. Department of Endocrinology, Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research, Chandigarh, India

    Naresh Sachdeva

Authors
  1. Jiyalal Harnot
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Sanjay Verma
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Sunit Singhi
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Naveen Sankhyan
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Naresh Sachdeva
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Bhavneet Bharti
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sanjay Verma.

Ethics declarations

Conflict of Interest

None.

Source of Funding

This work was supported by Indian Council of Medical Research (ICMR) which provided financial assistance for conducting thesis. (Grant No. 3/2/2012/PG-thesis-HRD).

Clinical Trial Registry

Central trial registry of India (CTRI/2012/05/002,621).

Electronic Supplementary Materials

ESM 1

(PDF 243 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Harnot, J., Verma, S., Singhi, S. et al. Comparison of 300,000 and 600,000 IU Oral Vitamin-D Bolus for Vitamin-D Deficiency in Young Children. Indian J Pediatr 84, 111–116 (2017). https://doi.org/10.1007/s12098-016-2233-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12098-016-2233-9

Keywords

Search

Navigation