Dataset Information

Effect of vitamin D₃-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway.

ABSTRACT:

Objective

Vitamin D is essential for the maintenance of calcium homeostasis and bone mineralization; and low serum 25-hydroxyvitamin D (s-25-(OH)D) concentrations are associated with increased bone turnover. However, there is a lack of randomized controlled trials that have investigated the effect of vitamin D treatment on bone turnover in immigrant populations. We aimed to investigate the effect of 16-week daily vitamin D₃ supplementation on bone formation marker serum procollagen type 1 amino-terminal propeptide (P1NP) and bone resorption marker C-terminal crosslinked telopeptide of type I collagen (CTX).

Design

Double-blind, randomized, placebo-controlled trial.

Setting

Immigrant community centers in Oslo, Norway.

Participants

251 healthy adults aged 18-50 years with a non-Western immigrant background were recruited.

Intervention

16 weeks of daily oral supplementation with either 10 μg vitamin D₃, 25 μg vitamin D₃, or placebo.

Main outcome measures

Difference in change during the 16-week intervention between the intervention groups combined (10 or 25 μg of vitamin D₃/day) and placebo, in serum P1NP and serum CTX.

Results

A total of 214 (85%) participants completed the study. S-25-(OH)D increased from 29 nmol/L at baseline to 49 nmol/L in the intervention group with no significant change in the placebo group. However, there was no difference in change of serum P1NP (mean difference: - 1.2 μg/L (95% CI: - 5.4, 2.9, P = 0.6)) and serum CTX (mean difference: - 0.005 μg/L (95% CI: - 0.03, 0.02, P = 0.7)) between those receiving vitamin D₃ supplementation compared with placebo. The plasma PTH had decreased by a mean of - 1.97 pmol/L (95% CI: - 2.7, - 1.3, P < 0.0001) in the vitamin D₃ group compared to placebo.

Conclusions

Supplementation with 10 or 25 μg oral vitamin D₃ during winter and spring for 16 weeks did not significantly affect serum P1NP and serum CTX, despite increasing s-25(OH)D and decreasing PTH in a healthy immigrant population with low baseline vitamin D status. Trial registration number: NCT01263288.

SUBMITTER: Madar AA

PROVIDER: S-EPMC5365165 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of vitamin D<sub>3</sub>-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway.

Madar Ahmed A AA Knutsen Kirsten V KV Stene Lars C LC Brekke Mette M Lagerløv Per P Meyer Haakon E HE Macdonald Helen M HM

Bone reports 20150521

<h4>Objective</h4>Vitamin D is essential for the maintenance of calcium homeostasis and bone mineralization; and low serum 25-hydroxyvitamin D (s-25-(OH)D) concentrations are associated with increased bone turnover. However, there is a lack of randomized controlled trials that have investigated the effect of vitamin D treatment on bone turnover in immigrant populations. We aimed to investigate the effect of 16-week daily vitamin D<sub>3</sub> supplementation on bone formation marker serum procol ...[more]

PMID: 28377958

Similar Datasets

Project description:ObjectiveDespite the suggested role of vitamin D in the prevention of diabetes and cardiovascular disease or its risk factors, the evidence is not consistent and there is a paucity of randomized controlled trials in this field. We aimed to investigate the effect of 16-week daily vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, body mass index (BMI), and serum lipids.DesignDouble-blind, randomized, placebo-controlled trial.SettingImmigrant community centers in Oslo, Norway.Participants251 healthy adults aged 18-50 years with a non-Western immigrant background. All participants performed the baseline test and 215 (86%) returned to the follow-up test.Intervention16 weeks of daily oral supplementation with either 10 μg vitamin D3, 25 μg vitamin D3, or placebo.Main outcome measuresDifference in absolute change during the 16-week intervention between the intervention groups combined (10 or 25 μg of vitamin D3/day) and placebo, in HbA1c, fructosamine, serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), and BMI.ResultsA total of 215 (86%) participants completed the study. Serum 25-hydroxyvitamin D increased from 29 nmol/L at baseline to 49 nmol/L after intervention, with little change in the placebo group. However, there was no difference in change of HbA1c between those receiving vitamin D3 compared with placebo (mean difference: 0.01% (95% CI -0.04 to 0.06, p=0.7)). Neither did the vitamin D3 supplementation have any effect on the other end points: fructosamine, serum lipids, and BMI.Conclusions16-week vitamin D3 supplementation to healthy immigrants from South Asia, the Middle East, or Africa and now living in Norway with low vitamin D status did not improve HbA1c, fructosamine, lipid profiles, or BMI. An updated meta-analysis of similar published trials showed that our results were generally consistent with those of other studies.Trial registration numberNCT01263288.

Project description:Background: Vitamin D is considered to modulate T-cell function, which has been implicated in the treatment of inflammatory conditions. However, there is limited knowledge on the effects of vitamin D and its influences on circulating T-cell profiles in humans, particularly in overweight Black individuals who are more likely to be vitamin D insufficient (serum 25(OH)D concentrations of ≤20 ng/mL). Thus, this study tested the hypothesis that vitamin D supplementation modulates T-cell composition, which is in a dose-dependent manner. Methods: A 16-week randomized, double-blinded, placebo-controlled trial of vitamin D3 supplementation was undertaken in 70 overweight/obese Black people (mean age = 26 years, 82% female) with 25 hydroxyvitamin D ≤ 20 ng/mL at baseline. Subjects were randomly assigned a supervised monthly oral vitamin D3 equivalent to approximately 600 IU/day (n = 17), 2000 IU/day (n = 18), 4000 IU/day (n = 18), or a placebo (n = 17). Fresh peripheral whole blood was collected and CD3+, CD4+ and CD8+ cell counts and percentages were determined by flow cytometry at baseline and at 16 weeks, among 56 subjects who were included in the analyses. Results: A statistically significant increase in CD3+% in the 2000 IU/day vitamin D3 supplementation group, and increases in CD4+% in the 2000 IU/day and 4000 IU/day vitamin D3 supplementation groups were observed (p-values < 0.05) from the changes in baseline to 16 weeks. Further adjustments for age, sex and BMI showed that 2000 IU/day vitamin D3 supplementation increased in CD3+ count, CD3%, CD4 count, and CD4%, as compared to the placebo group (p-values < 0.05). Moreover, the highest serum 25(OH)D quantile group had the highest CD3% and CD4%. Conclusions: Sixteen-week vitamin D3 supplementation increases peripheral blood T-cell numbers and percentages in overweight/obese Black patients with vitamin D insufficiency. This resulting shift in circulating T-cell composition, particularly the increase in T helper cells (CD4+ cells), suggests that vitamin D supplementation may improve immune function in Black individuals.

Project description:BackgroundMost studies on immigrant health focus on immigrant groups coming from extra-European and/or low-income countries. Little attention is given to self-rated health (SRH) in the context EU/EEA migration. To know more about health among European immigrants can provide new insights related to social determinants of health in the migration context. Using the case of Italian immigrants in Norway, the aim of this study was to (i) examine the levels of SRH among Italian immigrants in Norway as compared with the Norwegian and the Italian population, (ii) examine the extent to which the Italian immigrant perceived that moving to Norway had a positive or negative impact on their SRH; and (iii) identify the most important factors predicting SRH among Italian immigrants in Norway.MethodsA cross-sectional survey was conducted among adult Italian immigrants in Norway (n = 321). To enhance the sample's representativeness, the original dataset was oversampled to match the proportion of key sociodemographic characteristics of the reference population using the ADASYN method (oversampled n = 531). A one-sample Chi-squared was performed to compare the Italian immigrants' SRH with figures on the Norwegian and Italian populations according to Eurostat statistics. A machine-learning approach was used to identify the most important predictors of SRH among Italian immigrants.ResultsMost of the respondents (69%) rated their SRH as "good" or "very good". This figure was not significantly different with the Norwegian population, nor to the Italians living in Italy. A slight majority (55%) perceived that their health would have been the same if they continued living in Italy, while 23% perceived a negative impact. The machine-learning model selected 17 variables as relevant in predicting SRH. Among these, Age, Food habits, and Years of permanence in Norway were the variables with the highest level of importance, followed by Trust in people, Educational level, and Health literacy.ConclusionsItalian immigrants in Norway can be considered as part of a "new mobility" of high educated people. SHR is shaped by several interconnected factors. Although this study relates specifically to Italian immigrants, the findings may be extended to other immigrant populations in similar contexts.

Project description:BackgroundInorganic arsenic is metabolized to monomethyl- (MMAs) and dimethyl- (DMAs) species via one-carbon metabolism (OCM); this facilitates urinary arsenic elimination. OCM is influenced by folate and vitamin B12 and previous randomized control trials (RCTs) showed that folic acid (FA) supplementation increases arsenic methylation in adults. This RCT investigated the effects of FA + B12 supplementation on arsenic methylation in children, a key developmental stage where OCM supports growth.MethodsA total of 240 participants (8-11 years, 53 % female) drinking from wells with arsenic concentrations > 50 μg/L, were encouraged to switch to low arsenic wells and were randomized to receive 400 μg FA + 5 μg B12 or placebo daily for 12-weeks. Urine and blood samples were collected at baseline, week 1 (only urine) and week 12. Generalized estimated equation (GEE) models were used to assess treatment effects on arsenic species in blood and urine.ResultsAt baseline, the mean ± SD total blood and urinary arsenic were 5.3 ± 2.9 μg/L and 91.2 ± 89.5 μg/L. Overall, total blood and urine arsenic decreased by 11.7% and 17.6%, respectively, at the end of follow up. Compared to placebo, the supplementation group experienced a significant increase in the concentration of blood DMAs by 14.0% (95% CI 5.0, 25.0) and blood secondary methylation index (DMAs/MMAs) by 0.19 (95% CI: 0.09, 0.35) at 12 weeks. Similarly, there was a 1.62% (95% CI: 0.43, 20.83) significantly higher urinary %DMAs and -1.10% (95% CI: -1.73, -0.48) significantly lower urinary %MMAs in the supplementatio group compared to the placebo group after 1 week. The direction of the changes in the urinary %iAs, %MMAs, and %DMAs at week 12 were consistent with those at week 1, though estimates were not significant. Treatment effects were stronger among participants with higher baseline blood arsenic concentrations. Results were consistent across males and females, and participants with higher and lower folate and B12 status at baseline.ConclusionThis RCT confirms that FA + B12 supplementation increases arsenic methylation in children as reflected by decreased MMAs and increased DMAs in blood and urine. Nutritional interventions may improve arsenic methylation and elimination in children, potentially reducing arsenic toxicity while also improving nutritional status.

Project description:IntroductionWe have previously shown that immigrants have lower attendance in BreastScreen Norway than non-immigrants and that non-Western immigrants have lower incidence of breast cancer, but more advanced disease.PurposeTo compare breast cancer-specific survival for immigrants versus non-immigrants diagnosed with screen-detected or symptomatic breast cancer.Material and methodsWe analyzed data from 28,320 women aged 50-69 diagnosed with breast cancer after being invited to BreastScreen Norway. We divided women into three groups; non-immigrants, immigrants from Western countries and immigrants from non-Western countries. We stratified our analyses according to detection mode (screen-detected breast cancer, interval cancer and cancer detected outside screening), and used cox regression to model the association between immigrants/non-immigrants and time to breast cancer death.ResultsAmong screen-detected breast cancers, 28.7% were histologic grade 3 among immigrants from non-Western countries compared to 21.3% among non-immigrants. Interval cancers and cancers detected outside screening had larger tumor diameter and a higher percentage were histologic grade 3 and lymph node positive among immigrants from non-Western countries compared to non-immigrants. Hazard ratio (95% confidence interval) adjusted for age and year of diagnosis for time to breast cancer death compared to non-immigrants was 0.70 (0.39-1.27) for immigrants from Western countries and 0.52 (0.23-1.17) for immigrants from non-Western countries.ConclusionDespite more advanced histopathological tumor characteristics among immigrants from non-Western countries compared to non-immigrants, we did not observe statistically significant differences in breast-cancer specific survival between the two groups. Keeping in mind the low number of breast cancer deaths and possible overestimation of survival among immigrants, this might imply that equity in outcome can be achieved through adequate follow-up and treatment despite inequal access.

Dataset Information

Effect of vitamin D₃-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway.

Objective

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusions

Publications

Effect of vitamin D<sub>3</sub>-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Effect of vitamin D3-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway.

Objective

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusions

Publications

Effect of vitamin D<sub>3</sub>-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Effect of vitamin D₃-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway.