A randomized double blind, placebo controlled study of vitamin D to ameliorate sickle cell chronic pain

Osunkwo, Ifeyinwa; Ziegler, Thomas R.; Alvarez, Jessica A.; George, Jacob; Cherry, Korin; Rhodes, James; Adisa, Olufolake; Ofori-Acquah, Solomon Fiifi; McCracken, C.; Ghosh, Samit; Eckman, James R.; Tangpricha, Vin; Dampier, Carlton

doi:10.1016/j.jpain.2012.01.302

Cited by 7 publications

(10 citation statements)

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“…A er removing duplicates, we screened 14 records and we excluded five records. When we assessed nine references to six studies for eligibility, we included one study (four references) (Osunkwo 2012) and excluded five studies (ACTRN12612000560897; Adewoye 2008; Dougherty 2015; NCT01276587; NCT01443728). Please refer to the study flow diagram which illustrates the selection process (Figure 1).…”

Section: Results Of the Searchmentioning

confidence: 99%

“…Please refer to the study flow diagram which illustrates the selection process (Figure 1). One study was included in this review (Osunkwo 2012).…”

Section: Results Of the Searchmentioning

confidence: 99%

“…One study was eligible for inclusion in this review (Osunkwo 2012). The risks of bias of the included study are summarised in Figure 2.…”

Section: Risk Of Bias In Included Studiesmentioning

confidence: 99%

“…The included study was described as randomised and reported that "the participants were stratified according to chronic pain status and randomised to either vitamin D or placebo" (Osunkwo 2012). Randomisation and allocation concealment were not explicitly described in the study report.…”

Section: Allocationmentioning

confidence: 99%

“…The included study was described as being double blind and vitamin D or placebo was dosed by weight and given weekly using a modified Stoss therapy regimen (Osunkwo 2012). From correspondence, all clinicians, CRAs, participants (and their parents or carers) were blinded.…”

Section: Blindingmentioning

confidence: 99%

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Vitamin D supplementation for sickle cell disease

Soe

Abas

Than

et al. 2017

Cochrane Database of Systematic Reviews

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We included only one low-quality clinical study which had a high risk of bias with regards to incomplete outcome data. Therefore, we consider that the evidence is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation (e.g. the Endocrine Society Clinical Practice Guidelines) and dietary reference intakes for calcium and vitamin D (e.g. from the USA Institute of Medicine). Evidence of vitamin D supplementation in sickle cell disease from high quality studies is needed. Well-designed, randomised, placebo-controlled studies of parallel design, are required to determine the effects and the safety of vitamin D supplementation in children and adults with sickle cell disease.

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Section: Results Of the Searchmentioning

confidence: 99%

“…Please refer to the study flow diagram which illustrates the selection process (Figure 1). One study was included in this review (Osunkwo 2012).…”

Section: Results Of the Searchmentioning

confidence: 99%

“…One study was eligible for inclusion in this review (Osunkwo 2012). The risks of bias of the included study are summarised in Figure 2.…”

Section: Risk Of Bias In Included Studiesmentioning

confidence: 99%

Section: Allocationmentioning

confidence: 99%

Section: Blindingmentioning

confidence: 99%

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Vitamin D supplementation for sickle cell disease

Soe

Abas

Than

et al. 2017

Cochrane Database of Systematic Reviews

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Vitamin D for the treatment of chronic painful conditions in adults

Straube

Derry

Straube

et al. 2015

Cochrane Database of Systematic Reviews

107

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Background This review is an update of a previously published review in the Cochrane Database of Systematic Reviews (Issue 1, 2010) on 'Vitamin D for the treatment of chronic painful conditions in adults'. Vitamin D is produced in the skin a er exposure to sunlight and can be obtained through food. Vitamin D deficiency has been linked with a range of conditions, including chronic pain. Observational and circumstantial evidence suggests that there may be a role for vitamin D deficiency in the aetiology of chronic painful conditions. Objectives To assess the e icacy and safety of vitamin D supplementation in chronic painful conditions when tested against placebo or against active comparators. Search methods For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE to February 2015. This was supplemented by searching the reference lists of retrieved articles, reviews in the field, and online trial registries. Selection criteria We included studies if they were randomised double-blind trials of vitamin D supplementation compared with placebo or with active comparators for the treatment of chronic painful conditions in adults. Data collection and analysis Two review authors independently selected the studies for inclusion, assessed methodological quality, and extracted data. We did not undertake pooled analysis due to the heterogeneity of the data. Primary outcomes of interest were pain responder outcomes, and secondary outcomes were treatment group average pain outcomes and adverse events. Main results We included six new studies (517 participants) in this review update, bringing the total of included studies to 10 (811 participants). The studies were heterogeneous with regard to study quality, the chronic painful conditions that were investigated, the dose of vitamin D given, co-interventions, and the outcome measures reported. Only two studies reported responder pain outcomes; the other studies reported treatment group average outcomes only. Overall, there was no consistent pattern that vitamin D treatment was associated with greater e icacy than placebo in any chronic painful condition (low quality evidence). Adverse events and withdrawals were comparatively infrequent, with no consistent di erence between vitamin D and placebo (good quality evidence).

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