- Research Article
- Open Access
Calcium vitamin D3 supplementation in clinical practice: side effect and satisfaction
© Sanaei et al. 2016
- Received: 30 November 2015
- Accepted: 6 March 2016
- Published: 10 March 2016
The Erratum to this article has been published in Journal of Diabetes & Metabolic Disorders 2017 16:39
The objective of this study was to assess side effects and satisfaction about OsteoCalVitFort (500 mg calcium and 400 I.U. of vitamin D3) usage.
A total 186 people were participated with range age from 18 to 65 years old. Each participant received 1 pack that contains 60 OsteoCalVitFort tablet and used two tablet OsteoCalVitFort daily (1 tablet after breakfast and 1 after dinner). By a phone call, side effects and satisfaction about OsteoCalVitFort were assessed.
The rate of constipating (8.0 %) and bloating (12.5 %) were decreased significantly after OsteoCalVitFort supplement intake (1.2 %, and 0.6 %, respectively). Similar results were observed in metallic taste in mouth, tiredness, weakness, loss of appetite, bone/muscle pain and mental/mood change after Calcium Vitamin D3 supplementation intake. Totally, 94 % of patients were satisfied about OsteoCalVitFort usage.
The results of the research indicate despite the high quality of OsteoCalVitFort supplement, there are no side effects which have been seen in other supplements.
- Vitamin D
- Side effect
There is little debate about calcium needs during lifespan for optimizing health in health of bone and out of bone [1, 2]. Many people are avoid or limit dairy products because of lactase intolerant, then they have no choice but to eat supplement [3–5]. Calcium supplements cause few, if any, side effects, unfortunately . Side effects can sometimes occur, including gas, constipation, bloating, nausea/vomiting, loss of appetite, mental/mood changes, and bone/muscle pain. Vitamin D3 is used to facilitate absorption of the calcium in the gut [7, 8], and to facilitate calcium incorporation in the bones. Low vitamin D levels are associated with impairment of the active absorption of calcium . Fortified Vitamin D3 with calcium without gastrointestinal side effect is a greatest effective factor to prevent bone loss [10–12]. OsteoCalVitFort seems more potent form of other Vitamin D and Calcium supplement (500 mg calcium and 400 I.U. of vitamin D3). The aim of this study was to evaluate side effects and satisfaction level of OsteoCalVitFort among people who consumed calcium supplement.
This study was single arm, prospective study that was done on 186 people who consumed Calcium supplement. Inclusion criteria were participants with age between 45 to 70 years old, in good health. Exclusion criteria were presence of any chronic illness such as chronic hepatic diseases, chronic kidney diseases, cardiac, hematologic, gastrointestinal, psychological problems, any diagnosed malignancy, history of active inflammatory illness, breast feeding, pregnancy, and history of kidney stone, hyperparathyroidism. After complete explanation of the study aim, informed consent from each participant was gathered.
Each participant received 1 pack that contains 60 OsteoCalVitFort tablet and used two tablet OsteoCalVitFort daily (1 tablet after breakfast and 1 after dinner). Side effects and satisfaction about OsteoCalVitFort consumption were assessed through case report form (CRF) by phone call.
This study was proposed and approved by the Ethics-in-Research Commission of Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences. Also, it has been registered on the Iranian clinical trial registration (www.irct.ir) as IRCT201312031414N30.
Data were analyzed by using the SPSS version 16 for Windows (SPSS Inc., Chicago, IL). The one–way ANOVA was used to determine the statistical significance of differences between the values for this study. Values of p < 0.05 were considered statistically significant.
The samples were composed of 166 (89.2 %) women and 20 (10.8 %) men with mean age of 52.78 ± 13.21, and 49.0 ± 16.50, respectively. The rate of low illiterate was 32.8 %, of illiterate was 1.07 %, of diploma was 36.2 %, and of high was 20.3 %.
Comparison of the previous and next effects of taking OsteoCalVitFort
Loss of appetite
Metallic taste in mouth
Totally, 94 % of participants were satisfaction with using OsteoCalVitFort supplement.
Osteoporosis is major medical issues at the community level and can be lead to excessive [13–17]. A study in Iran has shown that Osteoporosis is an important health challenge and increases with age and changes in life style . Dietary calcium is critical for the growth and development of the body skeleton and it seems plays a vital role in the prevention of osteoporosis . Many people are avoided dairy products because of lactase intolerant. In these situations, calcium supplements can help them meet their calcium requirements .
OsteoCalVitFort contain high amounts of vitamin D with calcium. The role of vitamin D is bone preservation by improving the absorption of calcium from food and reduce fractures in older . Most people who received Calcium, Vitamin D supplementation meet the gastrointestinal side effects and they are not satisfied for this obligatory administered by their physician. After consume of OsteoCalVitFort significant positive impact in constipating, bloating, metallic taste in mouth, thirst, tiredness, weakness, loss of appetite, and bone/muscle pain were observed.
The present study showed satisfaction level of OsteoCalVitFort intakes about 94 % of patients was satisfied. Consumers have multiple brands from which to choose but few assurances that the products are of high quality. Intake of OsteoCalVitFort can lead to Compensation amounts of Calcium and vitamin D. This supplement has no side effects. Satisfaction is a behavioral perspective on product consumer and it is too important that quality and satisfaction to be in a line.
The results of this survey have shown despite the high quality of OsteoCalVitFort supplement, there are not side effects which have been seen in other supplements.
We would like to thank all the patients who kindly participated in the study.
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Heaney RP. Calcium, dairy products and osteoporosis. J Am Coll Nutr. 2000;19(2):83S–99S.View ArticlePubMedGoogle Scholar
- Fleming KH, Heimbach JT. Consumption of calcium in the US: food sources and intake levels. J Nutr. 1994;124(8 Suppl):1426S–30S.PubMedGoogle Scholar
- Swagerty Jr D, Walling A, Klein R. Lactose intolerance. Am Fam Physician. 2002;65(9):1845.PubMedGoogle Scholar
- Bayless TM, Rosensweig NS. A racial difference in incidence of lactase deficiency: a survey of milk intolerance and lactase deficiency in healthy adult males. JAMA. 1966;197(12):968–72.View ArticlePubMedGoogle Scholar
- Heyman MB. Lactose intolerance in infants, children, and adolescents. Pediatrics. 2006;118(3):1279–86.View ArticlePubMedGoogle Scholar
- Riggs BL, O’Fallon WM, Muhs J, O’Connor MK, Kumar R, Melton LJ. Long-Term Effects of Calcium Supplementation on Serum Parathyroid Hormone Level, Bone Turnover, and Bone Loss in Elderly Women. J Bone Miner Res. 1998;13(2):168–74.View ArticlePubMedGoogle Scholar
- Bouillon R, Van Cromphaut S, Carmeliet G. Intestinal calcium absorption: molecular vitamin D mediated mechanisms. J Cell Biochem. 2003;88(2):332–9.View ArticlePubMedGoogle Scholar
- Boonen S, Lips P, Bouillon R, Bischoff-Ferrari HA, Vanderschueren D, Haentjens P. Need for additional calcium to reduce the risk of hip fracture with vitamin D supplementation: evidence from a comparative metaanalysis of randomized controlled trials. J Clin Endocrinol Metab. 2007;92(4):1415–23.View ArticlePubMedGoogle Scholar
- Nicolaysen R. Studies upon the mode of action of vitamin D: The influence of vitamin D on the absorption of calcium and phosphorus in the rat. Biochem J. 1937;31(1):122.View ArticlePubMedPubMed CentralGoogle Scholar
- Tang BM, Eslick GD, Nowson C, Smith C, Bensoussan A. Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis. Lancet. 2007;370(9588):657–66.View ArticlePubMedGoogle Scholar
- Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med. 1997;337(10):670–6.View ArticlePubMedGoogle Scholar
- Buckley LM, Leib ES, Cartularo KS, Vacek PM, Cooper SM. Calcium and Vitamin D3 Supplementation Prevents Bone Loss in the Spine Secondary to Low-Dose Corticosteroids in Patients with Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled Trial. Ann Intern Med. 1996;125(12):961–8.View ArticlePubMedGoogle Scholar
- Ray NF, Chan JK, Thamer M, Melton LJ. Medical expenditures for the treatment of osteoporotic fractures in the United States in 1995: report from the National Osteoporosis Foundation. J Bone Miner Res. 1997;12(1):24–35.View ArticlePubMedGoogle Scholar
- Cummings SR, Kelsey JL, Nevitt MC, O’DOWD KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiol Rev. 1985;7(1):178–208.View ArticlePubMedGoogle Scholar
- Kanis J, Johnell O, Oden A, Jonsson B, De Laet C, Dawson A. Risk of hip fracture according to the World Health Organization criteria for osteopenia and osteoporosis. Bone. 2000;27(5):585–90.View ArticlePubMedGoogle Scholar
- Bliuc D, Nguyen ND, Milch VE, Nguyen TV, Eisman JA. Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women. JAMA. 2009;301(5):513–21.View ArticlePubMedGoogle Scholar
- Johnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int. 2005;16(2):S3–7.View ArticlePubMedGoogle Scholar
- Bagheri P, Haghdoost A-A, Dortaj E, Halimi L, Vafayi Z, Farhangnia M, et al. Ultra Analysis of Prevalence of Osteoporosis in Iranian Women A Systematic Review and Meta-analysis. Iran J Endocrinol Metab. 2011;3.Google Scholar
- Lloyd T, Andon MB, Rollings N, Martel JK, Landis JR, Demers LM, et al. Calcium supplementation and bone mineral density in adolescent girls. JAMA. 1993;270(7):841–4.View ArticlePubMedGoogle Scholar