A randomised controlled trial comparing the efficacy of micellised and fat-soluble vitamin D3 supplementation in healthy adults

Published on Mar 22, 2019in British Journal of Nutrition3.718
· DOI :10.1017/S0007114518003215
Raman K. Marwaha29
Estimated H-index: 29
(International Life Sciences Institute),
Tanvi Dev3
Estimated H-index: 3
(AIIMS: All India Institute of Medical Sciences)
+ 9 AuthorsGomathy Sethuraman20
Estimated H-index: 20
: Nanoemulsion formulation of vitamin D3 have been shown to have better bioavailability than the coarse emulsion preparation in vitro and in vivo animal studies. In the absence of randomised trial in humans, comparing the efficacy of nanotechnology-based miscellised vitamin D3 over conventional vitamin D3, we undertook this study. A total of 180 healthy adults were randomised to receive either micellised (DePura, group A) or conventional vitamin D3 (Calcirol, group B) at a monthly dose of 60 000 IU (1500μg) for 6 months. The outcome parameters were serum 25-hydroxyvitamin D (25(OH)D), parathyroid hormone (PTH), Ca, phosphate, alkaline phosphatase and urinary Ca:creatinine ratio. A total of eighty-nine subjects in group A and seventy-seven in group B completed the trial. Subjects in both the groups had a significant increase in their serum 25(OH)D levels following supplementation (group A: 21·5 (sd 10·9) to 76·7 (sd 18·8) nmol/l (P<0·001); group B: 22·8 (sd 10·4) to 57·8 (sd 16·0) nmol/l (P<0·001)). Participants in micellised group had an additional increase of 20·2 (95 % CI 14·0, 26·4) nmol/l in serum 25(OH)D levels (P<0·001). The difference between the groups was 17·5 (95 % CI 11·8, 23·1) nmol/l, which remained statistically significant (P<0·001) even after adjustment for age and sex. Significant decline in mean serum PTH was observed in both the groups. No hypercalcaemia or hypercalciuria was noted. Although supplementation with both the preparations resulted in a significant rise in serum 25(OH)D levels, micellised vitamin D3 appeared to be more efficacious in achieving higher levels of serum 25(OH)D.
📖 Papers frequently viewed together
BACKGROUND: There is a high prevalence of vitamin D deficiency (VDD) in India. Molecular mechanisms suggest a strong relationship between vitamin D and growth factors. However, there is a paucity of literature with regard to a relationship between insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and vitamin D particularly in subjects with VDD. The objective of the study was to assess the relationship between growth factors and serum vitamin D-parathorm...
#1Alagu Selvi Kadappan (UMass: University of Massachusetts Amherst)H-Index: 1
#2Chi Guo (Hunan University)H-Index: 3
Last. Zhenhua Liu (UMass: University of Massachusetts Amherst)H-Index: 23
view all 7 authors...
SCOPE: Vitamin D (VD) is a fat-soluble vitamin that has a wide range of skeletal and non-skeletal functions. Although it can be synthesized through sun exposure and obtained from fortified foods, VD inadequacy is epidemic worldwide. Therefore innovative strategies are necessary for improving VD status. The present study examined VD absorption via nanoscale delivery systems. METHODS AND RESULTS: We examine the physical characteristics and in vitro bioaccessibility of cholecalciferol (VD3 ) in nan...
#1Verena Schwetz (Medical University of Graz)H-Index: 19
#2Christian Trummer (Medical University of Graz)H-Index: 17
Last. Stefan PilzH-Index: 79
view all 16 authors...
Bone turnover markers (BTMs) are used to evaluate bone health together with bone mineral density and fracture assessment. Vitamin D supplementation is widely used to prevent and treat musculoskeletal diseases but existing data on vitamin D effects on markers of bone resorption and formation are inconsistent. We therefore examined the effects of vitamin D supplementation on bone-specific alkaline phosphatase (bALP), osteocalcin (OC), C-terminal telopeptide (CTX), and procollagen type 1 N-terminal...
#1Ashley Lotito (Drexel University)H-Index: 1
#2Masaru Teramoto (UofU: University of Utah)H-Index: 14
Last. Deeptha Sukumar (Drexel University)H-Index: 11
view all 5 authors...
Obesity is often associated with vitamin D deficiency and secondary hyperparathyroidism. Vitamin D supplementation typically leads to the reductions in serum parathyroid hormone (PTH) levels, as shown in normal weight individuals. Meanwhile, the dose of vitamin D supplementation for the suppression of PTH may differ in overweight and obese adults. We conducted a systematic review and meta-analysis of randomized controlled trials to determine the dose of vitamin D supplementation required to supp...
BACKGROUND: Vitamin D deficiency is a widely recognized public health problem. Efficacy of a recently developed micellized form of vitamin D3 has not been studied. Hence, we undertook this study to compare its efficacy with the conventionally used fat-soluble vitamin D3. METHODS: In this open-labeled nonrandomized pilot study, we recruited 180 healthy children, aged 13-14 years in two groups and supplemented Group A (60 children) with 60,000 IU of fat-soluble vitamin D3/month with milk and Group...
#1Nasrin Sharifi (Ahvaz Jundishapur University of Medical Sciences)H-Index: 14
#2Reza Amani (Ahvaz Jundishapur University of Medical Sciences)H-Index: 22
Last. Bahman Cheraghian (Ahvaz Jundishapur University of Medical Sciences)H-Index: 17
view all 4 authors...
Evidence has revealed that vitamin D status is associated with the cardiometabolic risk factors. Moreover, few gender-specific analyses have been performed in the clinical trials regarding vitamin D supplementation. As a result, assessing gender differences regarding the effects of vitamin D supplementation on some cardiometabolic biomarkers in patients with non-alcoholic fatty liver disease (NAFLD) was the aim of present study. We conducted a post hoc subgroup analysis of a double blind placebo...
#1Samantha L. Margulies (GW: George Washington University)H-Index: 4
#2Divya Kurian (GW: George Washington University)H-Index: 1
Last. Zhiyong Han (GW: George Washington University)H-Index: 3
view all 4 authors...
There is a very high prevalence of vitamin D deficiency, which is defined by a serum level of 25-hydroxyvitamin D [25(OH)D] of lower than 20 ng/mL, in all populations of the world. Unfortunately, the prevalence of vitamin D deficiency in patients with intestinal malabsorption syndromes, including cystic fibrosis (CF), celiac disease (CD), short bowel syndrome and inflammatory bowel disease (IBD), is higher than that in the general population, indicating the presence of disease-specific causative...
#1Patrick Borel (AMU: Aix-Marseille University)H-Index: 67
#2Denis CaillaudH-Index: 32
Last. Noël Cano (University of Auvergne)H-Index: 37
view all 3 authors...
There has been renewed interest in vitamin D since numerous recent studies have suggested that besides its well-established roles in bone metabolism and immunity, vitamin D status is inversely associated with the incidence of several diseases, e.g., cancers, cardio-vascular diseases, and neurodegenerative diseases. Surprisingly, there is very little data on factors that affect absorption of this fat-soluble vitamin, although it is acknowledged that dietary vitamin D could help to fight against t...
#1Mir Sadat-Ali (UoD: University of Dammam)H-Index: 8
Abstract To assess the correlation of serum parathyroid hormone (PTH) and vitamin D (25-OHD) levels based on different assays for measuring 25-OHD in healthy Saudi Arabians living along the east coast. A cross-sectional study was conducted in 200 patients (150 women and 50 men aged between 18-69 years) between January 2011 and December 2012, attending outpatient clinic at King Fahd Hospital of the University, Al Khobar. The first 200 patients seen without vitamin D supplementation at clinic were...
Cited By4
#1Aislinn McCourt (UCD: University College Dublin)H-Index: 1
#2Steven L Mulrooney (UCD: University College Dublin)H-Index: 1
Last. Aifric O'Sullivan (UCD: University College Dublin)H-Index: 15
view all 5 authors...
In-vitro evidence suggests that the lipid component of foods alters vitamin D absorption. This single-blinded, cross-over postprandial study examined the effect of changing the lipid component of a 20 µg vitamin D3 fortified dairy drink on postprandial 25(OH)D concentrations. Participants consumed one dairy drink per visit: a non-lipid, a pre-formed oleic acid micelle, an olive oil and a fish oil dairy drink. There was a significant time*drink*baseline status effect on 25(OH)D concentrations (p ...
Abstract Vitamin D3 (cholecalciferol) is a lipophilic vitamin universally recognized as the calcium-absorbing factor. This vitamin plays a pivotal role in the maintenance of calcium homeostasis but also represents a fundamental factor to sustain immune function. Despite the widespread use of Vitamin D3 in form of supplements and drugs the issue of its overall bioavailability, after oral assumption, is frequently misjudge and taken for granted. Because of the large interindividual differences in ...
#1Meeta MeetaH-Index: 2
#2CV HarinarayanH-Index: 2
Last. Sushrut BabhulkarH-Index: 2
view all 6 authors...
#1Raman K. Marwaha (International Life Sciences Institute)H-Index: 29
#2Aashima Dabas (MAMC: Maulana Azad Medical College)H-Index: 6
Abstract Vitamin D deficiency is recognized as a pandemic affecting all ages and strata of population. The endogenous cutaneous synthesis of vitamin D is insufficient to maintain normal body requirement which necessitates the need for vitamin D supplementation or food-fortification. Conventional fat-soluble preparations of vitamin D have been traditionally used for prevention and therapeutic purposes. Recent advances in technology have enabled delivery of vitamin D through nanoemulsion formulati...
This website uses cookies.
We use cookies to improve your online experience. By continuing to use our website we assume you agree to the placement of these cookies.
To learn more, you can find in our Privacy Policy.