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Published in: Trials 1/2019

Open Access 01-12-2019 | Obesity | Study protocol

The effect of different amounts of vitamin D supplementation on serum calcidiol, anthropometric status, and body composition in overweight or obese nursing women: a study protocol for a randomized placebo-controlled clinical trial

Authors: Zohre Gerveieeha, Fereydoun Siassi, Mostafa Qorbani, Farzaneh Ziaeian, Gity Sotoudeh

Published in: Trials | Issue 1/2019

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Abstract

Background

The optimal vitamin D intake for nursing mothers with overweight or obesity has not been defined. Vitamin D concentrations are associated with body composition indices, particularly body fat mass. Few studies have investigated the relationship between hypovitaminosis D, obesity, anthropometric status, and body composition in nursing women. Thus, the present study aims to investigate whether vitamin D supplementation during lactation will improve vitamin D status, reduce body fat mass, and improve body composition.

Methods/design

In a double-blind, randomized, placebo-controlled, parallel-group trial, after term delivery, 90 healthy women with overweight or obesity will be selected and randomly allocated into three groups to receive 2000 IU/d cholecalciferol (vitamin D3), 4000 IU/d cholecalciferol, or placebo (lactose) for 12 weeks while nursing. Measurements of height, weight, waist circumference, and body composition (fat mass (kg), lean mass (kg), body fat (%), fat mass index, and relative fat mass index) will be taken for all subjects at baseline and after 12 weeks of intervention. In addition, serum 25-hydroxyvitamin D (25(OH)D), parathyroid hormone, calcium, and phosphorus will be measured.

Discussion

This study is the first investigating the effect of different amounts of vitamin D supplementation on serum calcidiol, anthropometric status, and body composition in nursing women with overweight or obesity. Our findings will contribute to the growing body of knowledge regarding the role of vitamin D supplementation in obesity, anthropometric status, and body composition in nursing women.

Trial registration

Iranian Registry of Clinical Trials IRCT201404130172​54N6. Registered on 11 April 2018.
Appendix
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Literature
1.
Ota E, Haruna M, Suzuki M, Anh DD, Tho LH, Tam NT, Thiem VD, Anh NT, Isozaki M, Shibuya K, Ariyoshi K. Maternal body mass index and gestational weight gain and their association with perinatal outcomes in Viet Nam. Bull World Health Organ. 2011;89:127–36.CrossRef
2.
Abedini Z, Ahmari Tehran H, Khorrami RA. Calorie intake and the related factors in lactating mothers referring to health centers. J Mazand Univ Med Sci. 2012;22(85):271-278 (Persian). 
3.
4.
Butte NF, Hopkinson JM, Mehta N, Moon JK, Smith EO. Adjustments in energy expenditure and substrate utilization during late pregnancy and lactation. Am J Clin Nutr. 1999;69(2):299–307.CrossRef
5.
McLean N, Griffin S, Toney K, Hardeman W. Family involvement in weight control, weight maintenance and weight-loss interventions: a systematic review of randomised trials. Int J Obes Relat Metab Disord. 2003;27(9):987.CrossRef
6.
Kugyelka JG, Rasmussen KM, Frongillo EA. Maternal obesity is negatively associated with breastfeeding success among Hispanic but not Black women. J Nutr. 2004;134(7):1746–53.CrossRef
7.
Stuebe AM, Oken E, Gillman MW. Associations of diet and physical activity during pregnancy with risk for excessive gestational weight gain. Am J Obstet Gynecol. 2009;201(1):58–e1.CrossRef
8.
Lacroix M, Battista MC, Doyon M, Moreau J, Patenaude J, Guillemette L, Ménard J, Ardilouze JL, Perron P, Hivert MF. Higher maternal leptin levels at second trimester are associated with subsequent greater gestational weight gain in late pregnancy. BMC Pregnancy Childbirth. 2016;16(1):62.
9.
Olson CM, Strawderman MS. Modifiable behavioral factors in a biopsychosocial model predict inadequate and excessive gestational weight gain. J Am Diet Assoc. 2003;103(1):48–54.CrossRef
10.
McAree T. Obesity and vitamin D deficiency–current concepts on their impact on pregnancy.Eur Endocrinol. 2013;9(2):125.CrossRef
11.
Gilmore LA, Klempel-Donchenko M, Redman LM. Pregnancy as a window to future health: excessive gestational weight gain and obesity. Semin Perinatol. 2015;39(4):296–303.CrossRef
12.
Wortsman J, Matsuoka LY, Chen TC, Lu Z, Holick MF. Decreased bioavailability of vitamin D in obesity. Am J Clin Nutr. 2000;72(3):690–3.CrossRef
13.
Mulligan ML, Felton SK, Riek AE, Bernal-Mizrachi C. Implications of vitamin D deficiency in pregnancy and lactation. Am J Obstet Gynecol. 2010;202(5):429–e1.CrossRef
14.
Pouraram H, Djazayery A, Mohammad K, Parsaeian M, Abdollahi Z, Motlagh AD, Djalali M, Khodaverdian K, Sotoudeh G, Yarparvar A, Heshmat R. Second national integrated micronutrient survey in Iran: Study design and preliminary findings. Arch Iran Med. 2018;21(4):137.PubMed
15.
Earthman CP, Beckman LM, Masodkar K, Sibley SD. The link between obesity and low circulating 25-hydroxyvitamin D concentrations: considerations and implications. Int J Obes Relat Metab Disord. 2012;36(3):387.CrossRef
16.
Schlabritz-Loutsevitch NE, Comuzzie AG, Mahaney MM, Hubbard GB, Dick EJ, Kocak M, Gupta S, Carrillo M, Schenone M, Postlethwaite A, Slominski A. Serum vitamin D concentrations in baboons (Papio spp.) during pregnancy and obesity. Comp Med. 2016;66(2):137–42.
17.
Abdollahi M, Mohammadi-Nasrabadi F, Houshiarrad A, Ghaffarpur M, Ghodsi D, Kalantari N. Socio-economic Differences in Dietary Intakes: The Comprehensive Study on Household Food Consumption Patterns and Nutritional Status of I.R. Iran. Nutrition and Food Sciences Research. 2014;1:19–26.
18.
Misra M, Pacaud D, Petryk A, Collett-Solberg PF, Kappy M. Vitamin D deficiency in children and its management: review of current knowledge and recommendations. Pediatrics. 2008;122(2):398–417.CrossRef
19.
Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(7):1911–30.CrossRef
20.
Yanoff LB, Parikh SJ, Spitalnik A, Denkinger B, Sebring NG, Slaughter P, McHugh T, Remaley AT, Yanovski JA. The prevalence of hypovitaminosis D and secondary hyperparathyroidism in obese Black Americans. Clin Endocrinol (Oxf). 2006;64(5):523–9.CrossRef
21.
Rontoyanni V, Avila J, Kaul S, Wong R, Veeranki S. Association between obesity and serum 25 (OH) D concentrations in older Mexican adults. Nutrients. 2017;9(2):97.CrossRef
22.
Yao Y, Zhu L, He L, Duan Y, Liang W, Nie Z, Jin Y, Wu X, Fang Y. A meta-analysis of the relationship between vitamin D deficiency and obesity. Int J Clin Exp Med. 2015;8(9):14977.
23.
Zittermann A, Ernst JB, Gummert JF, Börgermann J. Vitamin D supplementation, body weight and human serum 25-hydroxyvitamin D response: a systematic review. Eur J Nutr. 2014;53(2):367–74.CrossRef
24.
Carrelli A, Bucovsky M, Horst R, Cremers S, Zhang C, Bessler M, Schrope B, Evanko J, Blanco J, Silverberg SJ, Stein EM. Vitamin D storage in adipose tissue of obese and normal weight women. J Bone Miner Res. 2017;32(2):237–42.CrossRef
25.
Wang H, Xia N, Yang Y, Peng DQ. Influence of vitamin D supplementation on plasma lipid profiles: a meta-analysis of randomized controlled trials. Lipids Health Dis. 2012;11(1):42.CrossRef
26.
Golzarand M, Hollis BW, Mirmiran P, Wagner CL, Shab-Bidar S. Vitamin D supplementation and body fat mass: a systematic review and meta-analysis. Eur J Clin Nutr. 2018;72(10):1345.CrossRef
27.
Rejnmark L, Bislev LS, Cashman KD, Eiríksdottir G, Gaksch M, Grübler M, Grimnes G, Gudnason V, Lips P, Pilz S, Van Schoor NM. Non-skeletal health effects of vitamin D supplementation: A systematic review on findings from meta-analyses summarizing trial data. PLoS One. 2017;12(7):e0180512.CrossRef
28.
Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Pludowski P, Wygledowska G, Chazan B, Pawlus B, Zochowska A, Borszewska-Kornacka MK, Karczmarewicz E. Impact of vitamin D supplementation during lactation on vitamin D status and body composition of mother-infant pairs: a MAVID randomized controlled trial. PLoS One. 2014;9(9):e107708.CrossRef
29.
Roosta S, Kharadmand M, Teymoori F, Birjandi M, Adine A, Falahi E. Effect of vitamin D supplementation on anthropometric indices among overweight and obese women: A double blind randomized controlled clinical trial. Diabetes Metab Syndr. 2018;12(4):537–41.CrossRef
30.
Zhu W, Cai D, Wang Y, Lin N, Hu Q, Qi Y, Ma S, Amarasekara S. Calcium plus vitamin D 3 supplementation facilitated Fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial. Nutr J. 2013;12(1):8.
31.
Azar M, Sarkisian E, Food Composition Table of Iran, National Nutrition and Food Research Institute. Tehran: Shahid Beheshti University Press; 1980.
32.
Zehni K, Ashjaardalan A, et al. The serum level of 25 hydroxy vitamin D and factors affecting its level among students in Kurdistan University of Medical Sciences in 2015. Scientific Journal of Kurdistan University of Medical Sciences. 2015);20(5):1-10.
33.
Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund UL, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–95.
34.
Siddiqui SM, Chang E, Li J, Burlage C, Zou M, Buhman KK, Koser S, Donkin SS, Teegarden D. Dietary intervention with vitamin D, calcium, and whey protein reduced fat mass and increased lean mass in rats. Nutr Res. 2008;28(11):783–90.CrossRef
35.
Ward KA, Das G, Berry JL, Roberts SA, Rawer R, Adams JE, Mughal Z. Vitamin D status and muscle function in post-menarchal adolescent girls. J Clin Endocrinol Metab. 2009;94(2):559–63.CrossRef
36.
Vanlint S. Vitamin D and obesity. J Nutr. 2013;5(3):949–56.
Metadata
Title
The effect of different amounts of vitamin D supplementation on serum calcidiol, anthropometric status, and body composition in overweight or obese nursing women: a study protocol for a randomized placebo-controlled clinical trial
Authors
Zohre Gerveieeha
Fereydoun Siassi
Mostafa Qorbani
Farzaneh Ziaeian
Gity Sotoudeh
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3622-y

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