- Poster presentation
- Open Access
P02.165. A comparative effectiveness trial of high-quality vitamin D3 nutritional supplements to replete serum vitamin D
© Traub et al; licensee BioMed Central Ltd. 2012
- Published: 12 June 2012
- Effectiveness Trial
- Supplement Group
- Chewable Tablet
- Sufficient Control
- Klotho Protein
The primary aim is to compare the change in serum 25-OHD concentration between three forms of supplemental vitamin D3: a lipid-emulsified form administered in a sesame oil base, a non-emulsified chewable tablet, and a non-emulsified form administered to 25-hydroxycholecalciferol (25-OHD) insufficient <33ng/ml (75 nmol/ml) patients. The secondary aim is to compare the proportion of participants reaching an “optimal” 25-OHD concentration ≥33ng/ml (75 nmol/ml) between Vitamin D supplement groups following supplementation.
This three-arm, randomized clinical trial compared the difference in serum 25-OHD concentration between the three arms at baseline and after random administration of one of the three vitamin D preparations for 12-weeks at a dosage of 10,000 IU Vitamin D per day (N=60 vitamin D insufficient subjects and N=30 sufficient controls).
Enrollment occurred from August 2010 to August 2011. Vitamin D insufficient, age-eligible participants were enrolled in the study (N=66), with the addition of sufficient controls (n=37). Overall loss to follow up was n=11 (16.7%). Between group differences were not significant for age, gender, height, weight or baseline Vitamin D 25 status. One-way analysis of variance (ANOVA) was used to estimate the difference in between group means. The mean unadjusted intra-group increase in serum 25-OHD were: Group A, 33.3 ng/mL (95%CI 24.1 – 42.4); Group B, 33.5 ng/mL (95%CI 19.6 – 47.4 ng/mL); Group C, 53.6 (95%CI 40.7 – 66.4). The serum levels of 25OHD were significantly different between groups (p=0.0215), while the serum levels of 1,25-OH2D did not reach between group significance (p=0.4850). The proportion of participants reaching 25-OHD ≥33ng/ml were: Group A 100%; Group B 82%; and Group C 100%.
Between group differences reached significance for mean change in 25-OHD status. Final analysis of results will adjust for confounding, after which the treatment arm assignments will be un-blinded. Analysis of cardio-metabolic data, Klotho protein expression and TLR-4 expression are in process.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.