Vitamin D supplementation following hip fracture: what is the best dosing strategy ?
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(5):37 BMC Musculoskelet Disord. 2011 Jun 20;12:135. doi: 10.1186/1471-2474-12-13565 patients who had recently suffered an acute hip fracture were randomized to determine the effect of a vitamin D2 loading dose on serum 25-hydroxyvitamin D3 (25-OHD) levels. Patients were allocated to receive one of three loading doses on top of vitamin D3 supplementation: either a high-loading dose (100000 IU), a low-loading dose (50000 IU), or a placebo loading dose. Results after 3 months indicated that there was no significant effect of either active loading dose on serum 25-OHD levels.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Sim = 1
Incerto = 0,5
Não relevante = 0
Não = 0
A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.
4/4
Randomization
4/4
Outcome Measurements
2/4
Inclusion / Exclusion
3/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.
Porque é que este estudo era necessário agora?
Hip fracture patients are usually found to have insufficient levels of 25-hydroxyvitamin D3 (25-OHD), which has been demonstrated to have important implications in falls and fractures. A number of analyses have suggested that 800 to 1000 IU/day vitamin D3 supplementation can reduce falls and fractures, and are also consistently reduced when 25-OHD levels are at least 75nmol/L; however there has yet to be consensus on the optimal dosing strategy in these patients. This study aimed to evaluate the change in 25-OHD levels with a loading dose of vitamin D2 on top of daily supplementation with vitamin D3.
Qual era a principal questão de investigação?
Was there a difference in serum 25-OHD levels of acute hip fracture patients who received either a high, low or placebo loading dose of vitamin D2, combined with daily vitamin D3 supplementation, when measured over 3 months?
- Some baseline measurements of 25-OHD levels were taken after bolus administration of vitamin D2 or placebo; 25 patients (n=11, 6, and 8 for placebo, 50 000, and 100 000 groups, respectively) had serum collection 1-3 days after bolus. Measurements of 25-OHD levels in this time frame were 41.6nmol/L in the placebo group, 59.0nmol/L in the 50 000 IU group, and 76.0nmol/L in the 100 000 IU group (p=0.03), resulting in significant difference between the placebo and 100 000 group (post-hoc).
- Baseline measurement of 25-OHD levels in 34 patients (n=7, 14, and 13 for placebo, 50 000 IU, and 100 000 IU groups, respectively) prior to bolus were 58.7nmol/L in the placebo, 52.3nmol/L in the 50 000 IU, and 44.3nmol/L in the 100 000 IU group (p=0.39).
- Adjustment for time between bolus dose and 25-OHD measurement resulted in non-significant difference between groups (46.7nmol/L placebo, 53.5nmol/L 50 000 IU, 58.4nmol/L 100 000 IU; p=0.37).
- Mean 25-OHD levels at 4-week follow up were 69.3nmol/L in the placebo group, 84.5nmol/L in the 50 000 IU group, and 75.6nmol/L in the 100 00 IU group (p=0.15), with proportion of patients above 75nmol/L level at 47.1%, 58.8%, and 50.0% in the groups, respectively (p=0.76).
- No significant difference was observed between groups at 3 months, with 25-OHD levels at 86.7nmol/L in the placebo group, 84.2nmol/L in the 50 000 IU group, and 73.3nmol/L in the 100 000 IU group (p=0.09). Proportion of patients above 75nmol/L level in the 100 000 IU was 44.4%, compared to 76.5% and 75.0% in the placebo and 50 000 IU groups, respectively. This difference, however, was found to be not statistically significant (p=0.09).
- A total of 5 serious adverse events were reported: 2 deaths, 1 fractured hip, 1 pulmonary edema and myocardial infarction, and 1 gangrenous foot (which was amputated). One occurred in the placebo group and 2 each in the 50 000 IU and 100 000 IU groups. All were deemed not related to the study treatments.
De que é que me devo lembrar mais?
One-time bolus loading-doses of either 50 000 IU and 100 000 IU vitamin D2 prior to 90-day supplementation of 1000 IU/day vitamin D3 did not significantly increase 25-OHD levels over 3 months, nor the proportion of patients who presented with 25-OHD levels above 75nmol/L.
Como é que isto afectará o tratamento dos meus doentes?
The findings of this study suggest that an additional loading-dose of vitamin D2 does not increase 25-OHD levels compared to daily supplementation of vitamin D3 alone. It would be worthwhile to conduct an investigation into the effect of a vitamin D3 loading-dose along with daily supplementation, as it has been suggested that vitamin D3 is more efficiently metabolized in human physiology. Nonetheless, supplementation should be complimented with a safety analysis considering incidence of hypercalcemia.
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