scholarly journals A Parallel Randomised Controlled Trial of Single Dose Vitamin D3 Versus Daily Supplementation with Pentavite in Infants with Vitamin D Deficiency

2018 ◽  
Vol 3 (3) ◽  
Keyword(s):  
Vitamin D ◽  
Single Dose ◽  
Randomised Controlled Trial ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Vitamin D intake, serum 25-hydroxyvitamin D status and response to moderate vitamin D3 supplementation: a randomised controlled trial in East African and Finnish women

2018 ◽  
Vol 119 (4) ◽  
pp. 431-441 ◽  
Author(s):  
Folasade A. Adebayo ◽  
Suvi T. Itkonen ◽  
Taina Öhman ◽  
Essi Skaffari ◽  
Elisa M. Saarnio ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomised Controlled Trial ◽  
Ethnic Differences ◽  
Repeated Measures ◽  
Controlled Trial ◽  
East African ◽  
Hydroxyvitamin D ◽  
Vitamin D Intake ◽  
25 Hydroxyvitamin D ◽  
Randomised Controlled

AbstractInsufficient vitamin D status (serum 25-hydroxyvitamin D (S-25(OH)D)<50 nmol/l) is common among immigrants living at the northern latitudes. We investigated ethnic differences in response of S-25(OH)D to vitamin D3 supplementation, through a 5-month randomised controlled trial, in East African and Finnish women in Southern Finland (60°N) from December 2014 to May 2015. Vitamin D intakes (dietary and supplemental) were also examined. Altogether, 191 subjects were screened and 147 women (East Africans n 72, Finns n 75) aged 21–64 years were randomised to receive placebo or 10 or 20 µg of vitamin D3/d. S-25(OH)D concentrations were assessed by liquid chromatography–tandem MS. At screening, 56 % of East Africans and 9 % of Finns had S-25(OH)D<50 nmol/l. Total vitamin D intake was higher in East Africans than in Finns (24·2 (sd 14·3) v. 15·2 (sd 13·4) µg/d, P<0·001). Baseline mean S-25(OH)D concentrations were higher in Finns (60·5 (sd=16·3) nmol/l) than in East Africans (51·5 (sd 15·4) nmol/l) (P=0·001). In repeated-measures ANCOVA (adjusted for baseline S-25(OH)D), mean S-25(OH)D increased by 8·5 and 10·0 nmol/l with a 10-µg dose and by 10·7 and 17·1 nmol/l with a 20-µg dose for Finns and East Africans, respectively (P>0·05 for differences between ethnic groups). In conclusion, high prevalence of vitamin D insufficiency existed among East African women living in Finland, despite higher vitamin D intake than their Finnish peers. Moderate vitamin D3 supplementation was effective in increasing S-25(OH)D in both groups of women, and no ethnic differences existed in the response to supplementation.

scholarly journals Prevalence of Vitamin D Deficiency and Its Relationship with Clinical Outcomes in Patients with Fibromyalgia: a Systematic Review of the Literature

2022 ◽  
Vol 4 (1) ◽  
Author(s):  
Omar M. E. Ali
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Patient Flow ◽  
Controlled Trial ◽  
Cost Effective ◽  
Therapeutic Benefit ◽  
Vitamin D Supplementation ◽  
Effective Interventions ◽  
Randomised Controlled ◽  
And Control

Abstract Fibromyalgia is a debilitating chronic condition which poses a therapeutic challenge to the clinician. With a large backlog in patient flow subsequent to the COVID-19 pandemic and rising numbers of patients with post-acute sequelae of COVID-19 (PASC) presenting with fibromyalgia-like clinical features, there is an increasingly pressing need to identify broad cost-effective interventions. Low levels of vitamin D have previously been reported in patients with fibromyalgia, though any causative link has been difficult to establish. A systematic literature review on the association between vitamin D deficiency and fibromyalgia was performed examining retrospective evidence both for and against an association between vitamin D deficiency (VDD) and fibromyalgia and evaluating the therapeutic benefit from supplementation. A group of six studies were selected based on relevance, use of controls, quality of research and citations. Four primary studies assessing the prevalence of VDD in fibromyalgia patients versus controls were evaluated with a total 3,496 subjects. Three included females only and one larger study assessed males. Two (n = 313) concluded the presence of a statistically significant association, and two (n = 161) found none. Two randomised controlled trials assessing the effect of vitamin D supplementation in a total of 80 subjects found conflicting results, with pain reduction in one and none in the other. It is likely there exists an association between VDD deficiency and fibromyalgia in a large subset of patients, although establishing primary causation is difficult. There is a need for larger randomised controlled trial designs with more effective comparison with healthy subjects and control for confounding factors. Given VDD is a major problem in the general population, we recommend supplementation be recommended by healthcare professionals to fibromyalgia patients for the purpose of maintaining bone health given their potentially increased susceptibility to developing deficiency and its sequelae.

scholarly journals Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e031162 ◽  
Author(s):  
Ali Sie ◽  
Mamadou Bountogo ◽  
Eric Nebie ◽  
Mamadou Ouattara ◽  
Boubacar Coulibaly ◽  
...  
Keyword(s):  
Single Dose ◽  
Randomised Controlled Trial ◽  
San Francisco ◽  
Child Mortality ◽  
Controlled Trial ◽  
Hypertrophic Pyloric Stenosis ◽  
Institutional Review Boards ◽  
Infantile Hypertrophic Pyloric Stenosis ◽  
All Cause Mortality ◽  
Randomised Controlled

IntroductionBiannual mass azithromycin distribution to children aged 1–59 months has been shown to reduce all-cause mortality. Children under 28 days of age were not treated in studies evaluating mass azithromycin distribution for child mortality due to concerns related to infantile hypertrophic pyloric stenosis (IHPS). Here, we report the design of a randomised controlled trial to evaluate the efficacy and safety of administration of a single dose of oral azithromycin during the neonatal period.Methods and analysisTheNouveaux-nés et Azithromycine: une Innovation dans le Traitement des Enfants(NAITRE) study is a double-masked randomised placebo-controlled trial designed to evaluate the efficacy of a single dose of azithromycin (20 mg/kg) for the prevention of child mortality. Newborns (n=21 712) aged 8–27 days weighing at least 2500 g are 1:1 randomised to a single, directly observed, oral dose of azithromycin or matching placebo. Participants are followed weekly for 3 weeks after treatment to screen for adverse events, including IHPS. The primary outcome is all-cause mortality at the 6-month study visit.Ethics and disseminationThis study was approved by the Institutional Review Boards at the University of California, San Francisco in San Francisco, USA (Protocol #18-25027) and the Comité National d’Ethique pour la Recherche in Ouagadougou, Burkina Faso (Protocol #2018-10-123). The findings of this trial will be presented at local, regional and international meetings and published in open access peer-reviewed journals.Trial registration numberNCT03682653; Pre-results.

scholarly journals The Effect of High-Dose Postpartum Maternal Vitamin D Supplementation Alone Compared with Maternal Plus Infant Vitamin D Supplementation in Breastfeeding Infants in a High-Risk Population. A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1632 ◽  
Author(s):  
Adekunle Dawodu ◽  
Khalil M. Salameh ◽  
Najah S. Al-Janahi ◽  
Abdulbari Bener ◽  
Naser Elkum
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Serum Calcium ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Urine Calcium ◽  
Randomized Controlled ◽  
High Prevalence ◽  
Maternal Supplementation

In view of continuing reports of high prevalence of severe vitamin D deficiency and low rate of infant vitamin D supplementation, an alternative strategy for prevention of vitamin D deficiency in infants warrants further study. The aim of this randomized controlled trial among 95 exclusively breastfeeding mother–infant pairs with high prevalence of vitamin D deficiency was to compare the effect of six-month post-partum vitamin D3 maternal supplementation of 6000 IU/day alone with maternal supplementation of 600 IU/day plus infant supplementation of 400 IU/day on the vitamin D status of breastfeeding infants in Doha, Qatar. Serum calcium, parathyroid hormone, maternal urine calcium/creatinine ratio and breast milk vitamin D content were measured. At baseline, the mean serum 25-hydroxyvitamin D (25(OH)D) of mothers on 6000 IU and 600 IU (35.1 vs. 35.7 nmol/L) and in their infants (31.9 vs. 29.6) respectively were low but similar. At the end of the six month supplementation, mothers on 6000 IU achieved higher serum 25(OH)D mean ± SD of 98 ± 35 nmol/L than 52 ± 20 nmol/L in mothers on 600 IU (p < 0.0001). Of mothers on 6000 IU, 96% achieved adequate serum 25(OH)D (≥50 nmol/L) compared with 52%in mothers on 600 IU (p < 0.0001). Infants of mothers on 600 IU and also supplemented with 400 IU vitamin D3 had slightly higher serum 25(OH)D than infants of mothers on 6000 IU alone (109 vs. 92 nmol/L, p = 0.03); however, similar percentage of infants in both groups achieved adequate serum 25(OH)D ≥50 nmol/L (91% vs. 89%, p = 0.75). Mothers on 6000 IU vitamin D3/day also had higher human milk vitamin D content. Safety measurements, including serum calcium and urine calcium/creatinine ratios in the mother and serum calcium levels in the infants were similar in both groups. Maternal 6000 IU/day vitamin D3 supplementation alone safely optimizes maternal vitamin D status, improves milk vitamin D to maintain adequate infant serum 25(OH)D. It thus provides an alternative option to prevent the burden of vitamin D deficiency in exclusively breastfeeding infants in high-risk populations and warrants further study of the effective dose.

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