Dataset Information

Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care.

ABSTRACT:

Objective

To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip.

Design

Pragmatic open randomised controlled trial.

Setting

Practice nurse led clinics in primary care.

Participants

3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight (< 58 kg), smoker, family history of hip fracture, or fair or poor self reported health.

Intervention

Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group).

Main outcome measures

Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment, falls, and quality of life (measured with the SF-12).

Results

69% of the women who completed the follow-up questionnaire at 24 months were still taking supplements (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for hip fracture was 0.75 (0.31 to 1.78). The odds of a woman having a fall at six and 12 months was 0.99 and 0.98, respectively. Quality of life did not significantly differ between the groups.

Conclusion

We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture. Registration ISRCTN26118436, controlled trials registry.

SUBMITTER: Porthouse J

PROVIDER: S-EPMC557150 | biostudies-literature | 2005 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care.

Porthouse Jill J Cockayne Sarah S King Christine C Saxon Lucy L Steele Elizabeth E Aspray Terry T Baverstock Mike M Birks Yvonne Y Dumville Jo J Francis Roger R Iglesias Cynthia C Puffer Suezann S Sutcliffe Anne A Watt Ian I Torgerson David J DJ

BMJ (Clinical research ed.) 20050401 7498

<h4>Objective</h4>To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip.<h4>Design</h4>Pragmatic open randomised controlled trial.<h4>Setting</h4>Practice nurse led clinics in primary care.<h4>Participants</h4>3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight (< 58 kg), smoker, family history of hip fracture, or fair ...[more]

PMID: 15860827

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Project description:Introduction:Vitamin D is paramount to bone health and little is known about vitamin D's role in the prevention of stress fractures in high-risk athletes. This study consists of a prospective, cross-sectional analysis accompanied by a retrospective review for control comparison of vitamin D3 supplementation in high-risk athletes. Our hypothesis is that supplemental vitamin D3 treatment will decrease the occurrence of stress fractures in high-risk collegiate athletes. Materials and Methods:A total of 118 NCAA Division I athletes were recruited from 6 high-risk collegiate teams. Blood draws in August and February established baseline 25(OH)D levels. Subjects with serum 25(OH)D <30 ng/mL were supplemented with 50,000 IU of vitamin D3/week for 8 weeks. Treated subjects were re-tested to ensure serum 25(OH)D levels rose to sufficient status. All enrolled subjects were monitored for the development of stress fractures. A 5-year retrospective chart review of athletes from the same sports teams was conducted to determine the incidence of any reported stress fractures in the past. Results:Prospective: 112 of the 118 enrolled subjects were tested in August. Sixty-one demonstrated vitamin D sufficiency (40.2 ng/mL ±8.28) and 51 were either insufficient or deficient (22.7 ng/mL ±4.89). Of the 118 enrolled subjects, 104 were tested in February. Fifty-six demonstrated vitamin D sufficiency (40.7 ng/mL ±9.47) and 48 were insufficient or deficient (21.6 ng/mL ±5.87). Two stress fractures were diagnosed amongst our cohort of 118 student athletes (1.69%). Retrospective: 34 stress fractures were diagnosed in 453 subjects from 01/2010-05/2015 (7.51%). Amongst our athletic teams, the cross-country team specifically demonstrated a statistically significant decrease in stress fracture incidence (p<0.05). We also found a statistically significant reduction in stress fracture incidence amongst the current overall cohort compared to our retrospective cohort (p<0.05). Conclusion:In our population, almost half of the tested athletes proved to be vitamin D deficient. Hypovitaminosis D was prevalent throughout the winter months compared with the summer. With vitamin D3 supplementation, the stress fracture rate in our overall cohort demonstrated a statistically significant decrease from 7.51% to 1.65% (p=0.009).

Project description:AIM:To prospectively evaluate the effects of vitamin D3 on disease activity and quality of life in ulcerative colitis (UC) patients with hypovitaminosis D. METHODS:The study was a prospective double-blinded, randomized trial conducted at Community Regional Medical Center, Fresno, CA from 2012-2013. Patients with UC and a serum 25(OH)D level <30 ng/ml were eligible for the study. Enrolled subjects were randomized to receive either 2,000 IU or 4,000 IU of oral vitamin D3 daily for a total of 90 days. The Short IBD Questionnaire (SIBDQ) for quality of life, the Partial Mayo Score for UC disease activity and serum lab tests were compared between the two treatment groups. Matched pair t-tests were computed to assess differences between the vitamin D levels, CRP, UC disease activity and SIBDQ scores before and after vitamin D3 therapy using SPSS version 21. RESULTS:Eight UC patients received 2,000 IU/daily and ten UC patients received 4,000 IU/daily of vitamin D3 for 90 days. Vitamin D levels increased after 90 days of oral vitamin D3 in both dose groups. However, the increase in vitamin D levels after 90 days of oral vitamin D3, in the 4,000 IU group was significantly higher 16.80 ± 9.15 (p < 0.001) compared to the 2,000 IU group of vitamin D 5.00 ± 3.12 (p = 0.008). Normal vitamin D levels (>30 ng/dl) were achieved in four out of the ten UC patients (40%) in the 4,000 IU group and in one out of the eight UC patients (12%) in the 2,000 IU group. In the group receiving 4,000 IU/day of vitamin D3 the increase in quality life scores (SIBDQ) was significant 1.0 ± 1.0 (p = 0.017) but not in the 2,000 IU vitamin D3 group 0.1 ± 1.0 (p = 0.87). In the 2,000 IU of vitamin D3 group the mean decrease in the Partial Mayo UC Score was -0.5 ± 1.5 (p = 0.38) compared to -1.3 ± 2.9 (p = 0.19) in the 4,000 IU vitamin D3 group but this was not statistically significant. CRP levels decreased after 90 days of daily vitamin D3 in both the 2,000 IU group and 4,000 IU group by -3.0 ± 9.4 (p = 0.4) and -10.8 ± 35.0 (p = 0.36) respectively. CONCLUSION:Vitamin D3 at 4,000 IU/day is more effective than 2,000 IU/day in increasing vitamin D to sufficient levels in UC patients with hypovitaminosis D, however higher doses or treatment beyond ninety days may be required. Vitamin D3 may improve the quality of life in UC patients but clinically significant improvement is not yet established. The effect of vitamin D3 on UC disease activity is still unclear. Further larger studies are needed to investigate the effects of vitamin D in ulcerative colitis.

Project description:ObjectiveTo determine whether supplementation with vitamin D improves resilience to the adverse effects of earthquakes.DesignOpportunistic addition to an established randomised double blind placebo controlled trial.SettingChristchurch, New Zealand, where a prolonged series of catastrophic earthquakes beginning on 4 September 2010 occurred, which caused widespread destruction, fatalities, and extensive psychological damage.Participants322 healthy adults (241 women; 81 men) aged 18-67 who were already participating in the vitamin D and acute respiratory infections study (VIDARIS) between February 2010 and November 2011.InterventionParticipants were randomised to receive an oral dose of either 200,000 IU vitamin D3 monthly for two months then 100,000 IU monthly (n=161) or placebo (n=161) for a total of 18 months.Main outcome measureThis is a post hoc analysis from the previously published VIDARIS trial. The primary endpoint in the current analysis was the self reported effects and overall adverse impact of the Christchurch earthquakes as assessed by questionnaire four months after the most destructive earthquake on 22 February 2011, which was used as the index event. The secondary end point was the number of "psychological" adverse events that participants reported at their usual monthly appointments as part of the original VIDARIS trial.Results308 participants completed the earthquake impact questionnaire (n=152 in the vitamin D group and 156 in the placebo group). There was no significant difference in the number of self reported adverse effects between those receiving vitamin D supplementation and those receiving placebo. There was also no difference in the overall adverse impact score between treatment groups (χ(2) P=0.44). The exception was that those in the vitamin D group experienced more adverse effects on family relationships (22% v 13%; χ(2) P=0.03). The number of psychological adverse events-such as fatigue, stress, anxiety, and insomnia-that participants reported at their usual monthly appointments was significantly higher after the earthquake (χ(2) P=0.007) but did not differ between treatment groups.ConclusionIn this trial, vitamin D supplementation did not reduce the adverse impact of earthquakes in healthy adults. Trial registration Australian New Zealand Clinical Trials Registry (anzctr.org.au) ACTRN12609000486224.

Dataset Information

Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care.

Objective

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusion

Publications

Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care.

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