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A randomized double-blind placebo-controlled trial of vitamin D supplementation in juvenile-onset systemic lupus erythematosus: positive effect on trabecular microarchitecture using HR-pQCT.
Osteoporos Int 2018; 29(3):587-594OI

Abstract

In this randomized double-blind placebo-controlled 24-week trial, cholecalciferol supplementation at 50,000 IU/week effectively improved bone microarchitecture parameters in juvenile-onset systemic lupus erythematosus (JoSLE) patients, as assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT) at tibia site. An increase in the trabecular number and a decrease in the trabecular separation were observed, suggesting that vitamin D supplementation may be recommended for JoSLE patients with its deficiency.

INTRODUCTION

Vitamin D has an important effect on bone but there are no trials that directly address the boosting of serum levels of 25-hydroxyvitamin D (25OHD) in bone microarchitecture in JoSLE patients. The aim of this study was to evaluate the effect of vitamin D supplementation on bone microarchitecture parameters using HR-pQCT in JoSLE patients.

METHODS

This study was a randomized double-blind placebo-controlled 24-week trial. Forty female JoSLE patients were randomized (1:1) to receive oral cholecalciferol at 50,000 IU/week (JoSLE-VitD) or placebo (JoSLE-PL). The medications remained stable throughout the study. Serum levels of 25OHD were measured using a radioimmunoassay. The bone microarchitecture and volumetric bone density were analyzed using HR-pQCT at tibia site.

RESULTS

At baseline, the groups were similar with respect to their age, body mass index, organ involvement, glucocorticoid dose, immunosuppressant use, serum 25OHD levels, and HR-pQCT parameters. After 24 weeks, higher 25OHD levels were observed in the JoSLE-VitD group compared to the JoSLE-PL group [31.3 (8.6) vs. 16.5 (5.8) ng/mL, p < 0.001]. An increase in the trabecular number [∆Tb.N 0.16 (0.24) vs. 0.03 (0.19) 1/mm, p = 0.024] and a decrease in the trabecular separation [∆ThSp -0.045 (0.067) vs. 0.001 (0.009) mm, p = 0.017] were found in the JoSLE-VitD group compared to the JoSLE-PL group at tibia site. No differences were observed in other structural parameters [trabecular (Tb.Th) or cortical thickness (Ct.Th)], volumetric bone mineral densities, cortical porosity, and biomechanical parameters (p > 0.05).

CONCLUSION

This study suggests that cholecalciferol supplementation for 24 weeks effectively improved the bone microarchitecture parameters, mainly the trabecular number, in JoSLE patients.

TRIAL REGISTRATION

NCT01892748.

Authors+Show Affiliations

Division of Rheumatology, Hospital das Clinicas HCFMUSP Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.Division of Rheumatology, Hospital das Clinicas HCFMUSP Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.Division of Rheumatology, Hospital das Clinicas HCFMUSP Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.Division of Rheumatology, Hospital das Clinicas HCFMUSP Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.Division of Rheumatology, Hospital das Clinicas HCFMUSP Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil. rosamariarp@yahoo.com. Faculdade de Medicina da USP, Reumatologia, Av Dr Arnaldo, 455, 3° andar, sala 3193, Sao Paulo-SP, 01246-903, Brazil. rosamariarp@yahoo.com.

Pub Type(s)

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

Language

eng

PubMed ID

29152675

Citation

Lima, G L., et al. "A Randomized Double-blind Placebo-controlled Trial of Vitamin D Supplementation in Juvenile-onset Systemic Lupus Erythematosus: Positive Effect On Trabecular Microarchitecture Using HR-pQCT." Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, vol. 29, no. 3, 2018, pp. 587-594.
Lima GL, Paupitz JA, Aikawa NE, et al. A randomized double-blind placebo-controlled trial of vitamin D supplementation in juvenile-onset systemic lupus erythematosus: positive effect on trabecular microarchitecture using HR-pQCT. Osteoporos Int. 2018;29(3):587-594.
Lima, G. L., Paupitz, J. A., Aikawa, N. E., Alvarenga, J. C., & Pereira, R. M. R. (2018). A randomized double-blind placebo-controlled trial of vitamin D supplementation in juvenile-onset systemic lupus erythematosus: positive effect on trabecular microarchitecture using HR-pQCT. Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 29(3), pp. 587-594. doi:10.1007/s00198-017-4316-5.
Lima GL, et al. A Randomized Double-blind Placebo-controlled Trial of Vitamin D Supplementation in Juvenile-onset Systemic Lupus Erythematosus: Positive Effect On Trabecular Microarchitecture Using HR-pQCT. Osteoporos Int. 2018;29(3):587-594. PubMed PMID: 29152675.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized double-blind placebo-controlled trial of vitamin D supplementation in juvenile-onset systemic lupus erythematosus: positive effect on trabecular microarchitecture using HR-pQCT. AU - Lima,G L, AU - Paupitz,J A, AU - Aikawa,N E, AU - Alvarenga,J C, AU - Pereira,R M Rodrigues, Y1 - 2017/11/19/ PY - 2017/01/06/received PY - 2017/11/13/accepted PY - 2017/11/21/pubmed PY - 2017/11/21/medline PY - 2017/11/21/entrez KW - Bone density KW - Bone microarchitecture KW - Cholecalciferol KW - Juvenile systemic lupus erythematosus KW - Vitamin D SP - 587 EP - 594 JF - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA JO - Osteoporos Int VL - 29 IS - 3 N2 - : In this randomized double-blind placebo-controlled 24-week trial, cholecalciferol supplementation at 50,000 IU/week effectively improved bone microarchitecture parameters in juvenile-onset systemic lupus erythematosus (JoSLE) patients, as assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT) at tibia site. An increase in the trabecular number and a decrease in the trabecular separation were observed, suggesting that vitamin D supplementation may be recommended for JoSLE patients with its deficiency. INTRODUCTION: Vitamin D has an important effect on bone but there are no trials that directly address the boosting of serum levels of 25-hydroxyvitamin D (25OHD) in bone microarchitecture in JoSLE patients. The aim of this study was to evaluate the effect of vitamin D supplementation on bone microarchitecture parameters using HR-pQCT in JoSLE patients. METHODS: This study was a randomized double-blind placebo-controlled 24-week trial. Forty female JoSLE patients were randomized (1:1) to receive oral cholecalciferol at 50,000 IU/week (JoSLE-VitD) or placebo (JoSLE-PL). The medications remained stable throughout the study. Serum levels of 25OHD were measured using a radioimmunoassay. The bone microarchitecture and volumetric bone density were analyzed using HR-pQCT at tibia site. RESULTS: At baseline, the groups were similar with respect to their age, body mass index, organ involvement, glucocorticoid dose, immunosuppressant use, serum 25OHD levels, and HR-pQCT parameters. After 24 weeks, higher 25OHD levels were observed in the JoSLE-VitD group compared to the JoSLE-PL group [31.3 (8.6) vs. 16.5 (5.8) ng/mL, p < 0.001]. An increase in the trabecular number [∆Tb.N 0.16 (0.24) vs. 0.03 (0.19) 1/mm, p = 0.024] and a decrease in the trabecular separation [∆ThSp -0.045 (0.067) vs. 0.001 (0.009) mm, p = 0.017] were found in the JoSLE-VitD group compared to the JoSLE-PL group at tibia site. No differences were observed in other structural parameters [trabecular (Tb.Th) or cortical thickness (Ct.Th)], volumetric bone mineral densities, cortical porosity, and biomechanical parameters (p > 0.05). CONCLUSION: This study suggests that cholecalciferol supplementation for 24 weeks effectively improved the bone microarchitecture parameters, mainly the trabecular number, in JoSLE patients. TRIAL REGISTRATION: NCT01892748. SN - 1433-2965 UR - https://www.unboundmedicine.com/medline/citation/29152675/A_randomized_double_blind_placebo_controlled_trial_of_vitamin_D_supplementation_in_juvenile_onset_systemic_lupus_erythematosus:_positive_effect_on_trabecular_microarchitecture_using_HR_pQCT_ L2 - https://dx.doi.org/10.1007/s00198-017-4316-5 DB - PRIME DP - Unbound Medicine ER -