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A double-blind, randomized, placebo-controlled trial of combined calcitriol and ergocalciferol versus ergocalciferol alone in chronic kidney disease with proteinuria.
BMC Nephrol. 2017 01 14; 18(1):19.BN

Abstract

BACKGROUND

KDOQI guideline suggests that nutritional vitamin D should be supplemented in chronic kidney disease (CKD) patients who have vitamin D insufficiency/deficiency. However, there are scarce data regarding the additional benefit of active vitamin D supplement in CKD patients who were receiving nutritional vitamin D supplement. This study was conducted to explore the effect of adding active vitamin D to nutritional vitamin D supplement on proteinuria and kidney function in CKD with vitamin D insufficiency/deficiency.

METHODS

This double-blind, randomized placebo-controlled trial was performed to answer the above question. Sixty-eight patients with CKD stage 3-4, urine protein to creatinine ratio (UPCR) > 1 g/g, and serum 25OH-D level < 30 ng/mL were enrolled. Patients were randomly assigned to receive 12-week treatment with oral ergocalciferol plus placebo (n = 36) or oral ergocalciferol plus calcitriol (n = 32).

RESULTS

The mean baseline values of UPCR of both groups were comparable (3.6 ± 3.8 g/g in combined group and 3.5 ± 3.0 g/g in ergocalciferol group). Following 12-week treatment, there were significant reductions in UPCR from baseline in both groups (2.3 ± 2.1 g/g in combined group and 2.4 ± 2.0 g/g in ergocalciferol group). The percentage reductions in UPCR of both groups were not significantly different. The mean eGFR and blood pressure did not differ between baseline and 12-week follow-up and between both groups. No severe hypercalcemia or serious side effects were noted in both groups.

CONCLUSIONS

The proteinuria lowering effect of ergocalciferol in CKD patients with vitamin D deficiency was demonstrated. Additional calcitriol supplement did not have more effects on proteinuria.

TRIAL REGISTRATION

(Thai Clinical Trials Registry (TCTR) 20140929002). Date of registration: September 27, 2014.

Authors+Show Affiliations

Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand. pesancerinus@hotmail.com.Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28088187

Citation

Susantitaphong, Paweena, et al. "A Double-blind, Randomized, Placebo-controlled Trial of Combined Calcitriol and Ergocalciferol Versus Ergocalciferol Alone in Chronic Kidney Disease With Proteinuria." BMC Nephrology, vol. 18, no. 1, 2017, p. 19.
Susantitaphong P, Nakwan S, Peerapornratana S, et al. A double-blind, randomized, placebo-controlled trial of combined calcitriol and ergocalciferol versus ergocalciferol alone in chronic kidney disease with proteinuria. BMC Nephrol. 2017;18(1):19.
Susantitaphong, P., Nakwan, S., Peerapornratana, S., Tiranathanagul, K., Katavetin, P., Srisawat, N., Praditpornsilpa, K., & Eiam-Ong, S. (2017). A double-blind, randomized, placebo-controlled trial of combined calcitriol and ergocalciferol versus ergocalciferol alone in chronic kidney disease with proteinuria. BMC Nephrology, 18(1), 19. https://doi.org/10.1186/s12882-017-0436-6
Susantitaphong P, et al. A Double-blind, Randomized, Placebo-controlled Trial of Combined Calcitriol and Ergocalciferol Versus Ergocalciferol Alone in Chronic Kidney Disease With Proteinuria. BMC Nephrol. 2017 01 14;18(1):19. PubMed PMID: 28088187.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, randomized, placebo-controlled trial of combined calcitriol and ergocalciferol versus ergocalciferol alone in chronic kidney disease with proteinuria. AU - Susantitaphong,Paweena, AU - Nakwan,Siriwan, AU - Peerapornratana,Sadudee, AU - Tiranathanagul,Khajohn, AU - Katavetin,Pisut, AU - Srisawat,Nattachai, AU - Praditpornsilpa,Kearkiat, AU - Eiam-Ong,Somchai, Y1 - 2017/01/14/ PY - 2015/11/20/received PY - 2017/01/04/accepted PY - 2017/1/16/entrez PY - 2017/1/16/pubmed PY - 2017/11/29/medline KW - CKD KW - Calcitriol KW - Ergocalciferol KW - Proteinuria KW - Vitamin D deficiency SP - 19 EP - 19 JF - BMC nephrology JO - BMC Nephrol VL - 18 IS - 1 N2 - BACKGROUND: KDOQI guideline suggests that nutritional vitamin D should be supplemented in chronic kidney disease (CKD) patients who have vitamin D insufficiency/deficiency. However, there are scarce data regarding the additional benefit of active vitamin D supplement in CKD patients who were receiving nutritional vitamin D supplement. This study was conducted to explore the effect of adding active vitamin D to nutritional vitamin D supplement on proteinuria and kidney function in CKD with vitamin D insufficiency/deficiency. METHODS: This double-blind, randomized placebo-controlled trial was performed to answer the above question. Sixty-eight patients with CKD stage 3-4, urine protein to creatinine ratio (UPCR) > 1 g/g, and serum 25OH-D level < 30 ng/mL were enrolled. Patients were randomly assigned to receive 12-week treatment with oral ergocalciferol plus placebo (n = 36) or oral ergocalciferol plus calcitriol (n = 32). RESULTS: The mean baseline values of UPCR of both groups were comparable (3.6 ± 3.8 g/g in combined group and 3.5 ± 3.0 g/g in ergocalciferol group). Following 12-week treatment, there were significant reductions in UPCR from baseline in both groups (2.3 ± 2.1 g/g in combined group and 2.4 ± 2.0 g/g in ergocalciferol group). The percentage reductions in UPCR of both groups were not significantly different. The mean eGFR and blood pressure did not differ between baseline and 12-week follow-up and between both groups. No severe hypercalcemia or serious side effects were noted in both groups. CONCLUSIONS: The proteinuria lowering effect of ergocalciferol in CKD patients with vitamin D deficiency was demonstrated. Additional calcitriol supplement did not have more effects on proteinuria. TRIAL REGISTRATION: (Thai Clinical Trials Registry (TCTR) 20140929002). Date of registration: September 27, 2014. SN - 1471-2369 UR - https://www.unboundmedicine.com/medline/citation/28088187/A_double_blind_randomized_placebo_controlled_trial_of_combined_calcitriol_and_ergocalciferol_versus_ergocalciferol_alone_in_chronic_kidney_disease_with_proteinuria_ L2 - https://bmcnephrol.biomedcentral.com/articles/10.1186/s12882-017-0436-6 DB - PRIME DP - Unbound Medicine ER -