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Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial.
Arch Dis Child. 2014 Sep; 99(9):807-11.AD

Abstract

OBJECTIVE

To determine whether children with calcium-deficiency rickets have a better response to treatment with vitamin D and calcium than with calcium alone.

DESIGN

Randomised controlled trial.

SETTING

Jos University Teaching Hospital, Jos, Nigeria.

POPULATION

Nigerian children with active rickets treated with calcium carbonate as limestone (approximately 938 mg elemental calcium twice daily) were, in addition, randomised to receive either oral vitamin D2 50,000 IU (Ca+D, n=44) or placebo (Ca, n=28) monthly for 24 weeks.

MAIN OUTCOME MEASURE

Achievement of a 10-point radiographic severity score ≤1.5 and serum alkaline phosphatase ≤350 U/L.

RESULTS

The median (range) age of enrolled children was 46 (15-102) months, and baseline characteristics were similar in the two groups. Mean (±SD) 25-hydroxyvitamin D (25(OH)D) was 30.2±13.2 nmol/L at baseline, and 29 (43%) had values <30 nmol/L. Baseline alkaline phosphatase and radiographic scores were unrelated to vitamin D status. Of the 68 children (94% of original cohort) who completed 24 weeks of treatment, 29 (67%) in the Ca+D group and 11 (44%) in the Ca group achieved the primary outcome (p=0.06). Baseline 25(OH)D did not alter treatment group effects (p=0.99 for interaction). At the end of 24 weeks, 25(OH)D values were 55.4±17.0 nmol/L and 37.9±20.0 nmol/L in the Ca+D and Ca groups, respectively, (p<0.001). In the Ca+D and Ca groups, the final 25(OH)D concentration was greater in those who achieved the primary outcome (56.4±17.2 nmol/L) than in those who did not (37.7±18.5 nmol/L, p<0.001).

CONCLUSIONS

In children with calcium-deficiency rickets, there is a trend for vitamin D to improve the response to treatment with calcium carbonate as limestone, independent of baseline 25(OH)D concentrations.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov NCT00949832.

Authors+Show Affiliations

Department of Family Medicine, Mayo Clinic, Rochester, Minnesota, USA.Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, Minnesota, USA.MRC/Wits Developmental Pathways for Health Research Unit, Department of Paediatrics, University of the Witwatersrand, Johannesburg, South Africa.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

24748637

Citation

Thacher, Tom D., et al. "Vitamin D Treatment in Calcium-deficiency Rickets: a Randomised Controlled Trial." Archives of Disease in Childhood, vol. 99, no. 9, 2014, pp. 807-11.
Thacher TD, Fischer PR, Pettifor JM. Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial. Arch Dis Child. 2014;99(9):807-11.
Thacher, T. D., Fischer, P. R., & Pettifor, J. M. (2014). Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial. Archives of Disease in Childhood, 99(9), 807-11. https://doi.org/10.1136/archdischild-2013-305275
Thacher TD, Fischer PR, Pettifor JM. Vitamin D Treatment in Calcium-deficiency Rickets: a Randomised Controlled Trial. Arch Dis Child. 2014;99(9):807-11. PubMed PMID: 24748637.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial. AU - Thacher,Tom D, AU - Fischer,Philip R, AU - Pettifor,John M, Y1 - 2014/04/19/ PY - 2014/4/22/entrez PY - 2014/4/22/pubmed PY - 2014/10/22/medline SP - 807 EP - 11 JF - Archives of disease in childhood JO - Arch. Dis. Child. VL - 99 IS - 9 N2 - OBJECTIVE: To determine whether children with calcium-deficiency rickets have a better response to treatment with vitamin D and calcium than with calcium alone. DESIGN: Randomised controlled trial. SETTING: Jos University Teaching Hospital, Jos, Nigeria. POPULATION: Nigerian children with active rickets treated with calcium carbonate as limestone (approximately 938 mg elemental calcium twice daily) were, in addition, randomised to receive either oral vitamin D2 50,000 IU (Ca+D, n=44) or placebo (Ca, n=28) monthly for 24 weeks. MAIN OUTCOME MEASURE: Achievement of a 10-point radiographic severity score ≤1.5 and serum alkaline phosphatase ≤350 U/L. RESULTS: The median (range) age of enrolled children was 46 (15-102) months, and baseline characteristics were similar in the two groups. Mean (±SD) 25-hydroxyvitamin D (25(OH)D) was 30.2±13.2 nmol/L at baseline, and 29 (43%) had values <30 nmol/L. Baseline alkaline phosphatase and radiographic scores were unrelated to vitamin D status. Of the 68 children (94% of original cohort) who completed 24 weeks of treatment, 29 (67%) in the Ca+D group and 11 (44%) in the Ca group achieved the primary outcome (p=0.06). Baseline 25(OH)D did not alter treatment group effects (p=0.99 for interaction). At the end of 24 weeks, 25(OH)D values were 55.4±17.0 nmol/L and 37.9±20.0 nmol/L in the Ca+D and Ca groups, respectively, (p<0.001). In the Ca+D and Ca groups, the final 25(OH)D concentration was greater in those who achieved the primary outcome (56.4±17.2 nmol/L) than in those who did not (37.7±18.5 nmol/L, p<0.001). CONCLUSIONS: In children with calcium-deficiency rickets, there is a trend for vitamin D to improve the response to treatment with calcium carbonate as limestone, independent of baseline 25(OH)D concentrations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT00949832. SN - 1468-2044 UR - https://www.unboundmedicine.com/medline/citation/24748637/Vitamin_D_treatment_in_calcium_deficiency_rickets:_a_randomised_controlled_trial_ L2 - http://adc.bmj.com/cgi/pmidlookup?view=long&amp;pmid=24748637 DB - PRIME DP - Unbound Medicine ER -