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 ?g vitamin D3, 25 ?g vitamin D3, or placebo. MAIN OUTCOME MEASURES:Difference in change during the 16-week intervention between the intervention groups combined (10 or 25 ?g 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 ?g/L (95% CI: - 5.4, 2.9, P = 0.6)) and serum CTX (mean difference: - 0.005 ?g/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 ?g 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

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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

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Project description:Background and objectivesVitamin D supplements are prescribed to correct low circulating concentrations of 25-hydroxyvitamin D. In CKD, vitamin D metabolism is complicated by decreased conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by CYP27B1 and possibly decreased conversion of 25-hydroxyvitamin D to 24,25-dihydroxyvitamin D by CYP24A1. The aim of this study was to determine the effects of vitamin D2 supplementation on vitamin D metabolism in health and CKD.Design, setting, participants, & measurementsWe conducted a treatment-only intervention study of 25 individuals with CKD (eGFR<60 ml/min per 1.73 m2) and 44 individuals without CKD from three academic centers, all with screening 25-hydroxyvitamin D <30 ng/ml. Each participant was prescribed vitamin D2 (ergocalciferol) 50,000 IU orally twice weekly for 5 weeks. We tested whether changes in plasma concentrations of vitamin D metabolites and vitamin D metabolic ratios differed by CKD status. Plasma 1,25-dihydroxyvitamin D3-to-25-hydroxyvitamin D3 ratio and 24,25-dihydroxyvitamin D3-to-25-hydroxyvitamin D3 ratio were calculated as estimates of CYP27B1 and CYP24A1 function, respectively.ResultsWith treatment, plasma 25-hydroxyvitamin D2 and total 25-hydroxyvitamin D concentrations increased similarly for participants with and without CKD. For participants without CKD, 1,25-dihydroxyvitamin D2 increased (2.8±1.3-32.9±1.4 pg/ml), whereas 1,25-dihydroxyvitamin D3 decreased (45.6±1.9-14.6±1.9 pg/ml), resulting in no significant change in total 1,25-dihydroxyvitamin D; 1,25-dihydroxyvitamin D3-to-25-hydroxyvitamin D3 ratio decreased (3.0±0.2-1.7±0.2 pg/ng), and 24,25-dihydroxyvitamin D3-to-25-hydroxyvitamin D3 ratio increased (115.7±7.8-195.2±7.9 pg/ng). Individuals with CKD had lower baseline levels and smaller changes in magnitude for 1,25-dihydroxyvitamin D2 (2.1±1.6-24.4±1.6 pg/ml; P interaction =0.01), 1,25-dihydroxyvitamin D3-to-25-hydroxyvitamin D3 ratio (1.8±0.2-1.1±0.2 pg/ng; P interaction =0.05), and 24,25-dihydroxyvitamin D3-to-25-hydroxyvitamin D3 ratio (72.0±9.1-110.3±9.3 pg/ng; P interaction <0.001). Fibroblast growth factor-23 and parathyroid hormone were not significantly changed in either group.ConclusionsVitamin D2 supplementation decreases conversion of 25-hydroxyvitamin D3 to 1,25-dihydroxyvitamin D3 and induces vitamin D3 catabolism as evidenced by changes in D3 metabolites and vitamin D metabolic ratios. These effects occur without significant changes in fibroblast growth factor-23 or parathyroid hormone and are blunted in CKD.PodcastThis article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_08_02_CJASNPodcast_17_09.mp3.

Project description:Immigrants' utilization of primary health care (PHC) services differs from that of the host populations. However, immigrants are often classified in broad groups by continent of origin, and the heterogeneity within the same continent may hide variation in use among immigrant groups at a national level. Differences in utilization of PHC between sub-Saharan African immigrants have not received much attention.Registry-based study using merged data from the National Population Register and the Norwegian Health Economics Administration. African immigrants and their descendants registered in Norway in 2008 (36,366 persons) where included in this study. Using ?2 test and logistic regression models, we assessed the differences in the use of PHC, including general practitioner (GP) and emergency room (ER) services, and the distribution of morbidity burden for immigrants from Somalia, Ethiopia, Eritrea, and Gambia. For the analyses, we used the number of visits and medical diagnoses from each consultation registered by the physician.Among the total studied population, 66.1% visited PHC within 1 year. The diagnoses registered were similar for all four immigrants groups, regardless of country of origin. Compared to immigrants from Somalia, the age and sex adjusted odds ratios (OR) for use of GP were significantly lower for Ethiopians (OR 0.91; 0.86-0.97), Eritreans (OR 0.85; 0.79-0.91), and Gambians (OR 0.88; 0.80-0.97). Similarly, we also observed lower use of ER among Ethiopians (OR 0.88; 0.81-0.95), Eritreans (OR 0.56; 0.51-0.62) and Gambians (OR 0.81; 0.71-0.92). However, immigrants from Somalia reduced their use of PHC with longer duration of stay in Norway. Differences between groups persisted after further adjustment for employment status.Despite the similarities in diagnoses among the sub-Saharan African immigrant groups in Norway, their use of PHC services differs by country of origin and length of stay. It is important to assess the reasons for the differences in these groups to identify barriers and facilitators to access to healthcare for future interventions.

Project description:Vitamin D deficiency and rickets are more common in non-western immigrants and refugees than in the native population. Severe vitamin D deficiency (serum 25-hydroxyvitamin D <25 nmol/l) may occur in up to 50% of children and adults of non-western origin. They are not used to sunshine exposure due to the often excessive sunshine in the country of origin. They usually have a more pigmented skin. Non-western immigrants and refugees often wear skin-covering clothes due to religious or cultural tradition. The food contains little vitamin D with the exception of fatty fish. In addition, many immigrants have a low calcium intake. Complaints may include fatigue, pain in shoulders, ribs, lower back and thighs. Neonates and young children may have spasms and convulsions due to hypocalcemia. Older children and adolescents may have bone pain, muscle weakness and skeletal deformities. Widening of the wrist, chest deformities and bowing of the legs may occur, and longitudinal growth is delayed. In adults, muscle weakness and bone pain are predominant. Laboratory examination may show hypocalcemia and hypophosphatemia and elevated alkaline phosphatase. The serum 25(OH)D is below 25 nmol/l in case of severe vitamin D deficiency with symptoms. Impaired 25-hydroxylation or 1α-hydroxylation may occur in case of severe liver or renal disease or by genetic causes. Radiographs of wrists or knees may show widening of the growth plates and cupping of radius and ulna may confirm the diagnosis. In adolescents and adults, radiographs of painful bones may show pseudofractures or Looser zones. Rickets and osteomalacia are treated by vitamin D3 2000 IU/d in infants, 3000-6000 IU/d in older children in combination with calcium 500 mg /d. In osteomalacia, the adult vitamin D3 dose is 2000-3000 IU/d, combined with calcium 1000-2000 mg/d. Prevention of vitamin D deficiency can be done with vitamin D3 400-800 IU/d, depending on age. Nutritional measures include fortification of milk or other foods.

Project description:BackgroundObservational data suggest that low vitamin D status is associated with an increased incidence of pulmonary tuberculosis and mortality among people living with HIV. The primary aims of this study were to assess the effect of vitamin D3 supplementation on the risk of mortality and incidence of pulmonary tuberculosis among adults initiating antiretroviral therapy (ART).MethodsThis was a randomised, double-blind, placebo-controlled trial of vitamin D3 supplementation among adults living with HIV who initiated ART and had serum 25-hydroxyvitamin D concentrations of less than 30 ng/mL at four large HIV care and treatment centres in Dar es Salaam, Tanzania. Patients were excluded if they were younger than 18 years, pregnant at the time of randomisation, or were enrolled in any other clinical trial. Patients were randomly assigned 1:1 to receive either weekly oral 50 000 IU vitamin D3 supplements (cholecalciferol) for the first month of ART followed by daily 2000 IU vitamin D3 supplements or a matching weekly and daily placebo regimen. The randomisation list was computer-generated by a non-study statistician with sequence blocks of ten that were stratified by study clinic. Complete allocation concealment was ensured and patients, field team, and investigators were masked to group assignment. The trial follow-up duration was 1 year and the primary efficacy outcomes were death and incident pulmonary tuberculosis. An intention-to-treat analysis was followed for all-cause mortality; participants diagnosed with or receiving treatment for pulmonary tuberculosis at randomisation, or suspected to have tuberculosis at randomisation and who later had that diagnosis confirmed, were excluded from analyses of pulmonary tuberculosis incidence. Safety was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT01798680, and is completed.FindingsBetween Feb 24, 2014, and Feb 24, 2017, 6250 adults initiating ART had serum 25-hydroxyvitamin D screening, 4000 of whom were enrolled in the trial and followed up for 1 year (follow-up of all participants was completed on March 7, 2018). 2001 patients were randomly assigned to the vitamin D3 supplementation group, and 1999 to the placebo group. 415 deaths were recorded: 211 in the vitamin D3 group and 204 in the placebo group. Among all randomly assigned participants, there was no overall effect of vitamin D3 supplementation on the risk of mortality (hazard ratio [HR] 1·04, 95% CI 0·85-1·25; p=0·73). There was also no difference in the overall incidence of pulmonary tuberculosis between the vitamin D3 (50 events in 1812 patients analysed) and placebo groups (64 events in 1827 patients; HR 0·78, 0·54-1·13; p=0·19). The vitamin D3 regimen did not increase the risk of hypercalcaemia (three events in the vitamin D3 group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00). 101 hospital admissions were reported in the vitamin D3 group and 94 in the placebo group (incidence rate ratio 1·06, 95% CI 0·80-1·41; p=0·66).InterpretationAdditional research is needed before vitamin D3 supplementation should be considered for implementation in HIV care and treatment programmes for the prevention of pulmonary tuberculosis or mortality.FundingNational Institute of Diabetes and Digestive and Kidney Diseases.

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.

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

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