scholarly journals Vitamin D oral intermittent treatment (DO IT) study, a randomized clinical trial with individual loading regimen

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jean-Pierre Rothen ◽  
Jonas Rutishauser ◽  
Philipp N. Walter ◽  
Kurt E. Hersberger ◽  
Isabelle Arnet

AbstractComparison of several regimens of oral vitamin D including an individually calculated loading regimen with the aim of achieving serum values > 75 nmol/l. Interventional, randomized, 3-arm study in vitamin D-deficient outpatients. Participants were allocated to supplementation of 24,000 IU vitamin D monthly over three months, using either a monthly drinking solution (Vi-De 3) or capsule (D3 VitaCaps), or an individualized loading regimen with the capsules taken weekly. For the loading regimen, the cumulative dose was calculated according to baseline 25-hydroxy-vitamin D (25(OH)D) serum value and body weight. Main inclusion criteria were age ≥ 18 years and 25(OH)D serum concentration < 50 nmol/l. The primary outcome was 25(OH)D serum concentration one week after treatment termination. Secondary endpoints were patient’s preferences and adverse events. Full datasets were obtained from 52 patients. Mean 25(OH)D values were statistically significant higher after a loading regimen compared to a monthly administration of 24,000 IU vitamin D (76.4 ± 15.8 vs 61.4 ± 10.8 nmol/l; p < 0.01). All patients treated with the loading regimen reached sufficient 25(OH)D values > 50 nmol/l. Serum 25(OH)D values > 75 nmol/l were observed more frequently in patients taking the loading regimen (47% vs 11% drinking solution vs 12% capsules). Vitamin D-related adverse effects did not occur in any treatment groups. Capsules were preferred by 88.5% of the patients. Compared to treatments with monthly intake of 24,000 IU vitamin D, the intake of an individually calculated weekly loading regimen was able to raise serum concentrations > 50 nmol/l in all cases within a safe range.

2016 ◽  
Vol 20 (10) ◽  
pp. 1034-1039 ◽  
Author(s):  
Thomas Krams ◽  
◽  
M. Cesari ◽  
S. Guyonnet ◽  
G. Abellan van Kan ◽  
...  

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Claudia Suárez-Calleja ◽  
Jaime Aza-Morera ◽  
Tania Iglesias-Cabo ◽  
Adonina Tardón

Abstract Background Vitamin D is traditionally associated with the metabolism of calcium and phosphorus, a process essential for the mineralization of hard tissue such as bone or tooth. Deficiency of this vitamin is a problem worldwide, however. Given the possibly significant role of Vitamin D in odontogenesis in children, the objective of our study was to determine the influence of vitamin D levels in the blood on dental anomalies in children between 6 and 10 years of age, by means of 25-hydroxy vitamin D tests performed during pregnancy and the first years of life. Methods The data analyzed were sourced from data belonging to the INMA-Asturias birth cohort, a prospective cohort study initiated in 2004 as part of the INMA Project. The 25-hydroxy vitamin D (25(OH)D) test was performed with samples from 188 children in the INMA-Asturias birth cohort with a dental examination performed between 6 and 10 years of age. The samples were taken at three stages: in the mother at 12 weeks of gestation, and subsequently in the child at 4 and 8 years of age. Diet, nutritional and oro-dental hygiene habits were also analyzed by means of questionnaires. Results The results indicate a significant association between caries and correct or incorrect brushing technique. With incorrect brushing technique, the prevalence of caries was 48.89%, but this dropped to 22.38% with correct brushing technique. An association was also found between tooth decay and frequency of sugar intake. The prevalence of caries was 24.54% with occasional sugar intake, but this rose to 56% with regular sugar intake. On the other hand, levels < 20 ng/ml in both mother and child at 8 years of age would also be risk factors (ORgest = 2.51(1.01–6.36) and OR8years = 3.45(1.14–11.01)) for the presence of caries in children. The risk of caries practically tripled where 25(OH) D values were < 20 ng/ml. Conclusions Although incorrect brushing technique and regular sugar consumption was found to be the main cause of caries in the children, the low concentrations of vitamin D in the blood of the pregnant mothers may have magnified this correlation, indicating that the monitoring of vitamin D levels during pregnancy should be included in antenatal programmes. It is particularly striking that 50% of the children were deficient in vitamin D at the age of 4, and that dental floss was practically absent from regular cleaning routines.


2020 ◽  
Author(s):  
Jean-Pierre Rothen ◽  
Jonas Rutishauser ◽  
Philipp N Walter ◽  
Kurt E Hersberger ◽  
Isabelle Arnet

Abstract Background: To assess adherence to and preference for vitamin D substitution with different pharmaceutical forms and frequencies of administration.Methods: A focus group of stakeholders aimed at preparing the design of an interventional, randomized, cross-over study with 2 x 2 groups obtaining monthly or weekly vitamin D products in liquid or solid form for 3 months each. Dosage corresponds to cumulated amount of recommended 800 IU daily (5.600 IU weekly / 24.000 IU monthly). Main inclusion criteria were a vitamin D serum value <50 nmol/l and age ≥18 years. Primary endpoint was adherence, secondary endpoints were preferences and vitamin D serum levels. Results: The focus group reached consensus for preference of a monthly administration of solid forms to adults. Full datasets were obtained from 97 participants. Adherence was significantly higher with monthly (79.5 – 100.0%) than weekly (66.4 – 98.1 %) administration. Vitamin D levels increased significantly (p<0.001) in all participants. An optimal value of >75 nmol/l was achieved by 32% after 3 months and by 50% after 6 months. Preferred formulation was solid form (tablets, capsules) for 71% of participants, and preferred dosage frequency was monthly for 39% of participants.Conclusions: Monthly oral vitamin D in solid form lead to the highest adherence, and is preferred by the participants. However, only one third of study participants achieved values in the optimal range of >75 nmol/l cholecalciferol using weekly or monthly administration providing an average daily cholecalciferol dose of 800 IU.


2009 ◽  
Vol 102 (3) ◽  
pp. 382-386 ◽  
Author(s):  
Ravinder Goswami ◽  
Raman Kumar Marwaha ◽  
Nandita Gupta ◽  
Nikhil Tandon ◽  
Vishnubhatla Sreenivas ◽  
...  

25-Hydroxy vitamin D (25(OH)D) deficiency is linked with predisposition to autoimmune type 1 diabetes and multiple sclerosis. Our objective was to assess the relationship between serum 25(OH)D levels and thyroid autoimmunity. Subjects included students, teachers and staff aged 16–60 years (total 642, 244 males, 398 females). Serum free thyroxine, thyroid-stimulating hormone (TSH), and thyroid peroxidase autoantibodies (TPOAb), intact parathyroid hormone and 25(OH)D were measured by electrochemiluminescence and RIA, respectively. Thyroid dysfunction was defined if (1) serum TSH ≥ 5 μU/ml and TPOAb>34 IU/ml or (2) TSH ≥ 10 μU/ml but normal TPOAb. The mean serum 25(OH)D of the study subjects was 17·5 (sd 10·2) nmol/l with 87 % having values ≤ 25 nmol/l. TPOAb positivity was observed in 21 % of subjects. The relationship between 25(OH)D and TPOAb was assessed with and without controlling for age and showed significant inverse correlation (r − 0·08, P = 0·04) when adjusted for age. The prevalence of TPOAb and thyroid dysfunction were comparable between subjects stratified according to serum 25(OH)D into two groups either at cut-off of ≤ 25 or >25 nmol/l or first and second tertiles. Serum 25(OH)D values show only weak inverse correlation with TPOAb titres. The presence of such weak association and narrow range of serum 25(OH)D did not allow us to interpret the present results in terms of quantitative cut-off values of serum 25(OH)D. Further studies in vitamin D-sufficient populations with wider range of serum 25(OH)D levels are required to substantiate the findings of the current study.


2012 ◽  
Vol 110 (1) ◽  
pp. 95-104 ◽  
Author(s):  
Priyanka Shankar ◽  
Sudip Ghosh ◽  
K. Bhaskarachary ◽  
K. Venkaiah ◽  
Arjun L. Khandare

The study was undertaken to explore the amelioration of chronic fluoride (F) toxicity (with low and normal Ca) in rats. The study was conducted in two phases. In phase I (6 months), seventy-six Wistar, weanling male rats were assigned to four treatment groups: normal-Ca (0·5 %) diet (NCD), Ca+F − ; low-Ca (0·25 %) diet (LCD), Ca − F − ; NCD +100 parts per million (ppm) F water, Ca+F+; LCD +100 ppm F water, Ca − F+. In phase II (reversal experiment, 3 months), LCD was replaced with the NCD. Treatment groups Ca+F+ and Ca − F+ were divided into two subgroups to compare the effect of continuation v. discontinuation along with Ca supplementation on reversal of chronic F toxicity. In phase I, significantly reduced food efficiency ratio (FER), body weight gain (BWG), faecal F excretion, serum Ca and increased bone F deposition were observed in the treatment group Ca − F+. Reduced serum 25-hydroxy-vitamin D3, increased 1,25-dihydroxy-vitamin D3 and up-regulation of Ca-sensing receptor, vitamin D receptor and S100 Ca-binding protein G (S100G) were observed in treatment groups Ca − F −  and Ca − F+. In phase II (reversal phase), FER, BWG and serum Ca in treatment groups Ca − F+/Ca+F −  and Ca − F+/Ca+F+ were still lower, as compared with other groups. However, other variables were comparable. Down-regulation of S100G was observed in F-fed groups (Ca+F+/Ca+F+ and Ca − F+/Ca+F+) in phase II. It is concluded that low Ca aggravates F toxicity, which can be ameliorated after providing adequate Ca and F-free water. However, chronic F toxicity can interfere with Ca absorption by down-regulating S100G expression irrespective of Ca nutrition.


2020 ◽  
Author(s):  
Jean-Pierre Rothen ◽  
Jonas Rutishauser ◽  
Philipp N Walter ◽  
Kurt E Hersberger ◽  
Isabelle Arnet

Abstract Background To assess adherence to and preference for vitamin D substitution with different pharmaceutical forms and frequencies of administration. Methods A focus group of stakeholders aimed at preparing the design of an interventional, randomized, cross-over study with 2 x 2 groups obtaining monthly or weekly vitamin D products in liquid or solid form for 3 months each. Dosage corresponds to cumulated amount of recommended 800 IU daily (5.600 IU weekly / 24.000 IU monthly). Main inclusion criteria were a vitamin D serum value <50 nmol/l and age ≥18 years. Primary endpoint was adherence, secondary endpoints were preferences and vitamin D serum levels. Results The focus group reached consensus for preference of a monthly administration of solid forms to adults. Full datasets were obtained from 97 participants. Adherence was significantly higher with monthly (79.5 – 100.0%) than weekly (66.4 – 98.1%) administration. Vitamin D levels increased significantly (p<0.001) in all participants. An optimal value of >75 nmol/l was achieved by 32% after 3 months and by 50% after 6 months. Preferred formulation was solid form (tablets, capsules) for 71% of participants, and preferred dosage frequency was monthly for 39% of participants. Conclusions Monthly oral vitamin D in solid form lead to the highest adherence, and is preferred by the participants. However, only one third of study participants achieved values in the optimal range of >75 nmol/l cholecalciferol using weekly or monthly administration providing an average daily cholecalciferol dose of 800 IU.


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