A randomized double-blind placebo-controlled trial of vitamin D supplementation in adolescents and young adults with Juvenile-onset SLE: Improvement in disease activity and fatigue scores
Arthritis Care and Research, DOI: 10.1002/acr.22621
Glauce L Lima1, Juliane Paupitz1, Nadia E Aikawa1,2, Liliam Takayama1, Eloisa Bonfa1 andRosa M. R. Pereira1,*
1Division of Rheumatology, Faculdade de Medicina da Universidade de São Paulo, Brazil
2Pediatric Rheumatology Unit, Faculdade de Medicina da Universidade de São Paulo, Brazil
*Corresponding author: Rosa Maria Rodrigues Pereira, Faculdade de Medicina da USP, Reumatologia, Av Dr Arnaldo, 455, 3º andar, sala 3193, Sao Paulo - SP - Brazil, 01246-903, Phone number: +55 11 30618594; Fax: +55 11 30617490, e-mail: rosamariarp at yahoo.com
Purpose: Vitamin D has an important immunomodulatory effect, but there are no trials that directly addressed the boosting of serum levels of 25-hydroxyvitamin D (25OHD) in Juvenile-onset Systemic Lupus Erythematosus (JoSLE). The aim of this study was to evaluate the effect of vitamin D supplementation on disease activity and fatigue in JoSLE.
Methods: This study was a randomized double-blind placebo-controlled 24-week trial. Forty JoSLE patients were randomized (1:1) to receive oral cholecalciferol 50,000 IU/week (JoSLE-VitD) or placebo (JoSLE-PL). Medications remained stable throughout the study. Serum levels of 25OHD were measured using radioimmunoassay. Disease activity was assessed using the SLE Disease Activity Index (SLEDAI) and the European Consensus Lupus Activity Measurement (ECLAM). Fatigue was assessed using the Kids Fatigue Severity Scale (K-FSS).
Results: At baseline, groups were similar regarding, age, body mass index, organ involvement, glucocorticoid dose, use of immunosuppressive drugs, SLEDAI, ECLAM, K-FSS and levels of 25OHD. After 24 weeks, the mean level of 25OHD was higher in the JoSLE-VitD group than in the JoSLE-PL (p<0.001).At the end of intervention, a significant improvement in SLEDAI (p=0.010) and a tendency for ECLAM (p=0.076) was observed in the JoSLE-VitD group compared to the JoSLE-PL. Regarding fatigue evaluation, a reduction of fatigue related to social life score was found in the JoSLE-VitD group compared to the JoSLE-PL group (p=0.008). Cholecalciferol was well tolerated with no serious adverse events.
Conclusion: This study suggests that cholecalciferol supplementation for 24 weeks is effective in decreasing disease activity and improving fatigue in JoSLE patients. This article is protected by copyright. All rights reserved.
Snip from PDF
Measure | Vitamin D | Placebo |
Fatigue Easily | 3.65 ==> 3.05%%%= -0.6 | 4.4 ==> 4.75%%% = +0.35 |
Fatigue interfere with social life | 3.55 ==> 2.60%%%= -0.95 | 3.50 ==> 4.1%%%= +0.60 |
Vitamin D Level at 6 months | 31 ng | 17 ng |
- This was just barely enough vitamin D on average to make a difference
- If they had increased the dose for higher BMI subjects the average vitamin D level would have increased from 31 ng to approx 40 ng
- Note below: A doctor in Brazil uses about 10X the dose of vitamin D to CURE patients of various autoimmune diseases
See also VitaminDWiki
- If Lupus in family – 5 times more likely to get Lupus if low vitamin D and poor CYP24A1 – June 2016
- Lupus associated with both low vitamin D and Vitamin D receptor problems – April 2016
- 1000 IU per kg Vitamin D for autoimmune diseases – Coimbra Aug 2013 much higher dose to CURE - also in Brazil
For a person weighing 50 kg, the recommended vitamin D dose would be 50,000 IU DAILY, rather than 50,000 IU WEEKLY - Video by Dr. Coimbra – 95 percent of auto-immune cured with vitamin D in high doses - April 2014
- Autoimmune category listing has
204 items along with related searches - Brazillian petition to permit high vitamin D doses for autoimune diseases – Aug 2014
- Lupus flares totally eliminated by loading dose then 100000 IU of vitamin D each month – Oct 2012
- Lupus reduced with vitamin D intervention – Feb 2014
- Lupus category listing has
78 items along with related searches Juvenile Lupus fatigue reduced by vitamin D ( 50,000 IU weekly for 6 months) – RCT May 20157464 visitors, last modified 20 Jul, 2017, This page is in the following categories (# of items in each category)