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A randomized controlled trial of vitamin D replacement strategies in pediatric CF patients.
J Cyst Fibros 2016; 15(2):234-41JC

Abstract

BACKGROUND

Vitamin D insufficiency is common in children with cystic fibrosis (CF), yet data are sparse regarding the most effective form of vitamin D supplementation. The aim of this study was to compare two different vitamin D replacement regimens.

METHODS

We conducted a randomized controlled trial comparing 50,000 IU of ergocalciferol (vitamin D2) twice weekly for 8 weeks versus 50,000 IU of cholecalciferol (vitamin D3) weekly in patients with CF, pancreatic insufficiency, age 6-21 years and a 25(OH)D<30 ng/mL. The primary outcome was change in serum 25(OH)D concentration. For secondary analyses, we examined changes in IgG, IgE and CRP in patients who normalized their vitamin D levels.

RESULTS

A total of 47 patients completed the trial. The mean pre-treatment 25(OH)D concentration was 23.1 (SD 4.7) ng/mL. The overall mean increase in 25(OH)D was 11.1 (11.9) ng/mL and 31/47 (66%) achieved a 25(OH)D concentration ≥ 30 ng/mL; of the 26 participants who received D2, 18 (69%) achieved sufficiency while 13/21 (62%) participants treated with D3 achieved sufficiency. There was no difference between groups in change of 25(OH)D (p=0.65). Similarly, there was no difference in the number of patients to achieve vitamin D sufficiency between treatments (p=0.6).

CONCLUSIONS

Ergocalciferol administered as 50,000 IU twice weekly is as effective as cholecalciferol 50,000 IU weekly for 8 weeks in pediatric patients with CF and vitamin D insufficiency. Only 66% of the patients studied achieved the desired 25(OH)D concentration.

Authors+Show Affiliations

Boston Children's Hospital, Division of Respiratory Diseases, Harvard Medical School, 300 Longwood Ave, Boston, MA, United States. Electronic address: tsimoneau@connecticutchildrens.org.Boston Children's Hospital, Division of Respiratory Diseases, Harvard Medical School, 300 Longwood Ave, Boston, MA, United States.Clinical Research Center, Boston Children's Hospital, Boston, MA, United States.Clinical Research Center, Boston Children's Hospital, Boston, MA, United States.Hasbro Children's Hospital, Alpert Medical School of Brown University, Providence, RI, United States.

Pub Type(s)

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

Language

eng

PubMed ID

26211605

Citation

Simoneau, Tregony, et al. "A Randomized Controlled Trial of Vitamin D Replacement Strategies in Pediatric CF Patients." Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society, vol. 15, no. 2, 2016, pp. 234-41.
Simoneau T, Sawicki GS, Milliren CE, et al. A randomized controlled trial of vitamin D replacement strategies in pediatric CF patients. J Cyst Fibros. 2016;15(2):234-41.
Simoneau, T., Sawicki, G. S., Milliren, C. E., Feldman, H. A., & Gordon, C. M. (2016). A randomized controlled trial of vitamin D replacement strategies in pediatric CF patients. Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society, 15(2), pp. 234-41. doi:10.1016/j.jcf.2015.07.004.
Simoneau T, et al. A Randomized Controlled Trial of Vitamin D Replacement Strategies in Pediatric CF Patients. J Cyst Fibros. 2016;15(2):234-41. PubMed PMID: 26211605.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized controlled trial of vitamin D replacement strategies in pediatric CF patients. AU - Simoneau,Tregony, AU - Sawicki,Gregory S, AU - Milliren,Carly E, AU - Feldman,Henry A, AU - Gordon,Catherine M, Y1 - 2015/07/23/ PY - 2015/02/26/received PY - 2015/07/02/revised PY - 2015/07/03/accepted PY - 2015/7/28/entrez PY - 2015/7/28/pubmed PY - 2017/1/14/medline KW - Bone health KW - Cystic fibrosis KW - Nutrition KW - Pediatric KW - Vitamin D SP - 234 EP - 41 JF - Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society JO - J. Cyst. Fibros. VL - 15 IS - 2 N2 - BACKGROUND: Vitamin D insufficiency is common in children with cystic fibrosis (CF), yet data are sparse regarding the most effective form of vitamin D supplementation. The aim of this study was to compare two different vitamin D replacement regimens. METHODS: We conducted a randomized controlled trial comparing 50,000 IU of ergocalciferol (vitamin D2) twice weekly for 8 weeks versus 50,000 IU of cholecalciferol (vitamin D3) weekly in patients with CF, pancreatic insufficiency, age 6-21 years and a 25(OH)D<30 ng/mL. The primary outcome was change in serum 25(OH)D concentration. For secondary analyses, we examined changes in IgG, IgE and CRP in patients who normalized their vitamin D levels. RESULTS: A total of 47 patients completed the trial. The mean pre-treatment 25(OH)D concentration was 23.1 (SD 4.7) ng/mL. The overall mean increase in 25(OH)D was 11.1 (11.9) ng/mL and 31/47 (66%) achieved a 25(OH)D concentration ≥ 30 ng/mL; of the 26 participants who received D2, 18 (69%) achieved sufficiency while 13/21 (62%) participants treated with D3 achieved sufficiency. There was no difference between groups in change of 25(OH)D (p=0.65). Similarly, there was no difference in the number of patients to achieve vitamin D sufficiency between treatments (p=0.6). CONCLUSIONS: Ergocalciferol administered as 50,000 IU twice weekly is as effective as cholecalciferol 50,000 IU weekly for 8 weeks in pediatric patients with CF and vitamin D insufficiency. Only 66% of the patients studied achieved the desired 25(OH)D concentration. SN - 1873-5010 UR - https://www.unboundmedicine.com/medline/citation/26211605/A_randomized_controlled_trial_of_vitamin_D_replacement_strategies_in_pediatric_CF_patients_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1569-1993(15)00166-6 DB - PRIME DP - Unbound Medicine ER -