COMPARISON OF ORAL AND INJECTABLE VITAMIN D ON BONE MINERAL DENSITY IN PERI AND POSTMENOPAUSAL WOMEN WITH HYPOVITAMINOSIS D

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1 WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES Bharti et al. SJIF Impact Factor Volume 4, Issue 11, Research Article ISSN COMPARISON OF ORAL AND INJECTABLE VITAMIN D ON BONE MINERAL DENSITY IN PERI AND POSTMENOPAUSAL WOMEN WITH HYPOVITAMINOSIS D Nikita Kumari 1, *Dr. Rekha Bharti 2, Bindu Bajaj 3, Renuka Sinha 4, Pratima Mittal 5 1 Senior Resident, Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. *2 Assistant Professor, Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. 3 Senior Specialist, Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. 4 Consultant Gynaecologist, ADIVA Superspeciality Centre, Green Park, New Delhi, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi, Ex Consultant and Professor, Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. 5 Consultant, Professor and Head of the Department, Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi. Article Received on 14 Sept 2015, Revised on 05 Oct 2015, Accepted on 27 Oct 2015 *Correspondence for Author Dr. Rekha Bharti Assistant Professor, Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. ABSTRACT Background: Vitamin D deficiency in peri and postmenopausal women is associated with poor bone health and may lead to osteoporotic fractures. Supplimentation with Calcium and vitamin D by both oral and intramuscular routes improves serum vitamin D levels and bone mineral density (BMD) in postmenopausal women with hypovitaminosis D. Material & Methods: Women between 45 to 65 years were enrolled over a period of 6 months. Serum 25(OH)D levels were determined and women with vitamin D levels below <30 ng/ml were given vitamin D by either oral or intramuscular route along with oral calcium 1000 mg per day for 1 year. Baseline serum calcium and BMD at femur neck and lumber spine were done. The women were followed at 3, 6, 9 and 12 months after starting treatment with oral or intramuscular vitamin D. Serum 25(OH)D and calcium levels were done at each visit and BMD at femur neck and lumber spine were done at 6 and 12 months. Results: A total of 100 women were tested for vitamin D levels, 70% of these women had vitamin D levels <30 ng/ml. The response of both oral and intramuscular vitamin D on serum 25(OH)D levels was good, but after intramuscular vitamin D levels were sustained in Vol 4, Issue 11,

2 sufficient range for 12 months in 85.7% women as compared to 22.9% in the oral group. There was no difference in the serum calcium levels in both groups. The BMD at femur neck and lumber spine did not show any improvement after 6 and 12 months of therapy. Conclusion: Most of the women in the peri and postmenopausal age group have vitamin D deficiency. Vitamin D supplementation by both oral and intramuscular route is not associated with improvement of BMD at femur neck or lumber spine. KEYWORDS: vitamin D, bone mineral density, postmenopausal women, perimenopausal. INTRODUCTION Hypovitaminosis D is widely prevalent in India and is of concern especially in the peri and postmenopausal women, where osteoporosis may be the primary manifestation of vitamin D deficiency. [1] It is reported that 70-80% of postmenopausal women are vitamin D deficient. [2] Both, vitamin D deficiency and low calcium intake are important risk factors for osteoporosis. Vitamin D deficiency causes low bone mass, muscle weakness and therefore increased risk of fracture. Mild deficiency or insufficiency results in the loss of bone mass and osteoporosis whereas severe deficiency causes long standing secondary hyperparathyroidism leading to increased bone turnover causing osteoporotic fractures. [3,4] Menopause represents an important transition in vitamin D requirement because of the dependence of the vitamin D receptor (VDR) on oestrogen; making these women more susceptible to the deficiency state. [5] However, due to the lifestyle changes resulting in limited sunlight exposure, even premenopausal women are vulnerable to the deficiency of vitamin D. In India, the preference for type of clothing, use of sunscreen and darker skin pigment limits vitamin D synthesis in the skin despite of abundance of sunlight in this region. The sun exposure is further limited as more women are joining the work force. Therefore, women enter into menopause with a vitamin D deficient state. [6] Further, aging during menopause, affects multiple steps in the metabolism of vitamin D, beginning with the reduced efficiency in the vitamin D synthesis by aging skin upon exposure to UVB radiation. Consequently, to generate the same amount of vitamin D, the older women require approximately 3 times the duration of exposure as compared to the younger adult. [7] Mild vitamin D deficiency or insufficiency results in the loss of bone mass and osteoporosis whereas severe deficiency causes long standing secondary hyperparathyroidism leading to increased bone turnover causing osteoporotic fractures. [3,4] Vitamin D repletion with adequate calcium supplementation results in the suppression of secondary hyperparathyroidism. Vol 4, Issue 11,

3 Vitamin D treatment has been shown to reduce hip fracture by 50% in the elderly population. [8,9,10] Oral Vitamin D formulations are well absorbed from gut. Presence of bile is essential for adequate intestinal absorption. Absorbed vitamin D circulates in the blood in association with alpha globulin. It disappears from plasma with a half-life of hours but is stored in fat depots for prolonged period. Its primary route of excretion is bile. Vitamin D and its metabolites undergo extensive hepatic recirculation. Intramuscular Vitamin D3 is also available in an Arachis oil depot formulation in strength of 3 lakhs and 6 lakhs IU. Compliance with oral therapy may be low; hence it is important to know which route of administration is better - oral or parenteral. Although, the efficacy of oral vitamin D has been observed in many studies, there is paucity of literature comparing the efficacy of the oral with intramuscular vitamin D administration. [11,12] This study was designed to estimate the prevalence of vitamin D deficiency among peri and postmenopausal women presenting to tertiary care hospital. It also aimed to find out association of vitamin D deficiency with bone mineral density and to compare the efficacy of oral vs. intramuscular vitamin D on bone mineral density of these women. MATERIAL AND METHODS This study was a prospective, interventional study, conducted at the Department of Gynaecology in collaboration with the departments of Pathology and Radiodiagnosis, in a North India tertiary care hospital. Peri and postmenopausal women, 45 to 65 years old, attending Gynaecology and Menopausal clinics between November 2011 and April 2012, were included in the study. Women with history of calcium and vitamin D supplementation, hormonal replacement therapy in 12 months before recruitment, non-traumatic spine or hip fracture, bone mineral metabolism disorder or recent major gastrointestinal disease, were excluded from the study. After detailed history and examination, women willing to adhere to the study protocol were tested for vitamin D levels [25(OH) D], which was measured by sandwich ELISA technique using Immunodiagnostica kit. Women with insufficient or deficient vitamin D levels [25(OH)D<30ng/ml] were divided into 2 groups on alternate basis, one group was given oral vitamin D 3, 60,000 IU weekly for 10 doses. Second group was given single dose of 6 lac IU intramuscular vitamin D 3. Both groups were given 1 gram oral calcium for a period of one year. All women had DEXA scan and serum calcium measurement before starting vitamin D. Vol 4, Issue 11,

4 DEXA scan was done using, Osteoscore 3, Platinum DEXA scanner; the scans were taken from lumbar spine and femur neck, and T scores were obtained. The T score was interpreted according to WHO criteria, T score of -1.0 or higher was taken as normal, T score between and -2.5 was taken as osteopenia and T score of -2.5 and less was taken as osteoporosis. The two groups were followed at 3, 6, 9 and 12 months of starting vitamin D. At each visit serum calcium and vitamin D levels were repeated. BMD at both femur neck and lumbar spine was done at 6 and 12 months after starting treatment. At each visit, women were encouraged to complete 12 months follow up and were telephonically reminded of the scheduled visit 15 days in advance. STATISTICAL ANALYSIS The data was analyzed by using SPSS 16.0 static software. Chi square test was used to compare different parameters by converting them into categories. Data was analyzed by the following tests: student t-test to compare mean levels of parameters between the groups. Continuous variables were expressed as mean ± S.D. To determine the statistical significance under each group of different parameters from baseline to different points of time, paired t- test/ non parametric Wilcoxn Signed Rank test were used. The association between continuous variables was tested by linear correlation using Pearson s coefficient. Spearman s test was used for correlations. All tests were two-tailed and p 0.05 were considered to be statistically significant. RESULTS A total of 100, peri and postmenopausal women between 45 to 65 years of age were screened for vitamin D deficiency. Vitamin D insufficiency and deficiency [25(OH)D<30ng/ml] was diagnosed in 70 women. These women were assigned oral group (N=35), receiving 10 doses of 60,000 IU oral Vitamin D and intramuscular group (N=35) receiving single 6 lac IU intramuscular vitamin D. The age, occupation, socio-economic status and menopausal (peri and postmenopausal) status of women in oral and intramuscular groups was comparable (Table-1). The mean vitamin D levels at the time of recruitment were also comparable in both groups. The follow up mean vitamin D levels, serum calcium and T score at lumbar spine and femur neck are shown in Table- 2, 3 and 4, respectively. Vol 4, Issue 11,

5 Table 1: Demographic variables in women receiving oral and intramuscular vitamin D Demographic Variables Oral Group Intramuscular group p n(35) % n(35) % value Age (YEARS) > Occupation Housewife Working Socio-Economic Status Low Middle High Menopausal Status Perimenopausal Postmenopausal Table 2: Serum vitamin D levels in women receiving oral and intramuscular vitamin D Intramuscular GROUP Vitamin D 3 Day 0 Vitamin D 3 3 Month Vitamin D 3 6 Month Vitamin D 3 9 Month Vitamin D 3 12 Month Oral Minimum (n=35) Maximum Mean SD Intramuscular Minimum Maximum (n=35) Mean SD p value Table 3: Serum calcium in women receiving oral and intramuscular Vitamin D. Group Oral Calcium Day 0 Calcium 3 Month Calcium 6 Month Calcium 9 Month Calcium 12 Month Minimum Maximum Mean SD Minimum Maximum Mean SD p value Vol 4, Issue 11,

6 Group Oral Table 4: BMD at femur neck and Lumber spine in women receiving oral and intramuscular vitamin D. T Score Femur neck Day 0 T Score Femur neck 6 Month T Score Femur neck 12 months T score LS Day 0 T Score LS 6 Month T Score LS 12 months Min Max Mean SD Min Intra- Max Muscular Mean SD p value DISCUSSION Vitamin D plays a crucial role in the calcium homeostasis and, intake of both calcium and vitamin D is necessary to maintain bone health. [1] The deficiency of vitamin D is present worldwide and affects around one billion people. [13] In India also, due to low dietary intake of calcium and limited exposure to sun light along with declining oestrogen levels, approximately 93% of postmenopausal women are reported to have either deficient or insufficient vitamin D levels. [1] In the present study, 70% of peri and postmenopausal women had vitamin D levels below the sufficient range i.e. 25(OH)D<30ng/ml. The present study observed a positive correlation between the serum 25(OH)D levels and BMD at femoral neck (r=0.390, p=0.033); however, there was no correlation of vitamin D levels with BMD at lumbar spine. Our results are similar to that of Fradinger et al, who also observed positive correlation of vitamin D levels with BMD at femur neck but not with BMD at lumber spine. [14] Many authors have also reported association of hypovitaminosis D with lower BMD at femur neck. [2,14,15,16,17] Studies have also found correlation of vitamin D deficiency with lower lumbar spine BMD. [2,18] However, two studies by Marwaha et al and Sigurdsson et al, failed to observe any significant correlation between 25(OH)D levels and BMD at any site. [19,20] Vitamin D was well tolerated by both oral and intramuscular routes. After single intramuscular dose of vitamin D, increase in the serum 25(OH)D levels at the end of 12 months in the present study was 226% compared to an average rise of 128% reported by Terrence et al. [21] At 3 months and 6 months, the rise in mean vitamin D levels was Vol 4, Issue 11,

7 comparable in both groups, p=0.486 and p=0.182, respectively. However, at 9 months and 12 months mean vitamin D levels were significantly higher in intramuscular group as compared to the oral group, p=0.001 & p=0.000, respectively. At the end of 12 months only 22.9% women in oral group had vitamin D levels in the sufficient range as compared to 85.7% women in the intramuscular groups. Tellioglu reported rise in vitamin D levels to sufficient range in all women receiving intramuscular vitamin D as compared to 83.3% women in oral group and Berrie et al reported better effect with oral vitamin D, 76.2% vs. 57.1%, p= [11, 12] However, the observation period in both studies was only 3 months and follow up evaluation was not done to see whether vitamin D levels were maintained even after 3 months. Although, calcium and Vitamin D repletion has been reported to improve bone mineral [22, 23, 24, 25] density in postmenopausal women. The present study did not find any improvement in the BMD, 6 and 12 months after starting supplementation with vitamin D and calcium. The difference in the findings could be due to the shorter duration of follow up as compared to 2-3 years in previous studies. Also, the reported change in BMD is around 1% per year which is less than the error of the DEXA machine (usually in the range of 3%), used in the present study. CONCLUSION Most of the women in the peri and postmenopausal age group have vitamin D less than the sufficient range. Vitamin D supplementation by both oral and intramuscular route is associated with rise in serum vitamin D levels. Although, with intramuscular route the serum vitamin D levels are maintained for 12 months, there is no improvement in BMD by either route. Limitations: The study groups in the present study were patients attending tertiary care hospital and were not the representative of population at large; therefore, results may not be applicable to general population. Another limitation of the study was small sample size. ACKNOWLEDGEMENT We acknowledge the valuable contribution to the study by Dr J. S. Dhupia, Ex-consultant, Professor and Head, Department of Pathology and Dr B.B. Thukral, Consultant, Professor and Head, Department of Radiodiagnosis, Vardhman Mahavir Medical College & Safdarjung Hospital. Vol 4, Issue 11,

8 Declaration of interest: The authors report no conflicts of interest. Source of funding: Nil. Ethical clearance: Ethical clearance was taken from ethical committee of the institution. REFERENCES 1. Harinarayan CV, Joshi SR. Vitamin D status in India its implications and remedial measures. J Assoc Physicians India., 2009; 57: Harinarayan CV, Sachan A, Reddy PA, Satish KM, Prasad UV, Srivani P. Vitamin D status and bone mineral density in women of reproductive and postmenopausal age groups: a cross-sectional study from south India. J Assoc Physicians India., 2011; 59: Reginster JY. The high prevalence of inadequate serum vitamin D levels and implications for bone health. Curr Med Res Opin., 2005; 21: Riggs BL. Role of vitamin D- endocrine system in the pathophysiology of postmenopausal osteoporosis. J Cell Biochem., 2003; 88: Duque G, Abdaimi KE, Macoritto M. Estrogens (E2) regulate expression and response of 1,25-dihydroxyvitamin D3 receptors in bone cells: changes with aging and hormone deprivation. Biochem Biophys Res Commun., 2002; 299: Clemens TL, Adams JS, Henderson SL, Holick MF. Increased skin pigment reduces the capacity of skin to synthesize vitamin D3. Lancet., 1982; 1: MacLaughlin J, Holick MF. Aging decreases the capacity of human skin to produce vitamin D3. J Clin Invest., 1985; 76: Trivedi DP, Doll R, Khaw KT. Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial. BMJ., 2003; 326: Lilliu H, Pamphile R, Chapuy MC, Schulten J, Arlot M, Meunier PJ. Calcium Vitamin D supplementation is cost effective in hip fracture prevention. Maturitas., 2003; 44: Chapuy MC, Pamphile R, Paris E, Kempf C, Schlichting M, Arnaud S et al. Combined calcium and Vitamin D3 supplementation in elderly women: confirmation of reversal of secondary hyperparathyroidism and hip fracture risk- the Decalyos II study. Osteoporos Int., 2002; 13: Tellioglu A, Basaran S, Guzel R, Seydaoglu G. Efficacy and safety of high dose intramuscular or oral cholecalciferol in vitamin D deficient/insufficient elderly. Maturita., Vol 4, Issue 11,

9 2012; 72(4): Berrie C. Presentation title: Comparison of Oral Versus Intramuscular Treatment of Vitamin D Deficiency or Insufficiency 2011: Abstract P Holick MF. Vitamin D: evolutionary, physiological and health perspectives. Curr Drug Targets., 2011 Jan; 12(1): Fradinger EE, Zanchetta JR. Vitamin D and bone mineral density in ambulatory women living in Buenos Aires, Argentina. Osteoporos Int., 2001; 12(1): Arya V, Bhambri R, Godbole MM, Mithal A. Vitamin D status and its relationship with bone mineral density in healthy Asian Indians. Osteoporos Int., 2004; 15: Melin AL, Wilske J, Ringertz H, Saaf M vitamin D status, parathyroid function and femoral bone density in an elderly Swedish population living at home. Aging (Milano)., 1999; 11: Francisco B, Luiz G, Eduardo F, Daniela CL, Ana CT, Erik TD et al. Vitamin D deficiency and its relationship with bone mineral density among postmenopausal women living in tropics. Arq Bras Endocrinol Metab., 2010; 54: Narula R, Tauseef M, Ahmad IA, Agarwal K, Ashok A, Anjana A. Vitamin D deficiency among postmenopausal women with osteoporosis. J Clin Diagn Res., 2013; 7: Marwaha RK, Tandon N, Garg MK, Kanwar R, Narang A, Sastry A et al. Vitamin D status in healthy Indians aged 50 years and above. J Assoc Physicians India., 2011; 59: Sigurdsson G, Franzson L, Steingrimsdottir L, Sigvaldason H. The association between parathyroid hormone, vitamin D and bone mineral density in 70-year-old Icelandic women. Osteoporos Int., 2000; 11(12): Terrence H Diamond, Kenneth W Ho, Peter G Rohl and Matthew Meerkin. Annual intramuscular injection of a megadose of cholecalciferol for treatment of vitamin D deficiency: efficacy and safety data. Med J Aust., 2005; 183(1): Kärkkäinen M, Tuppurainen M, Salovaara K, Sandini L, Rikkonen T, Sirola J, et al. Effect of calcium and vitamin D supplementation on bone mineral density in women aged years: a 3-year randomized population-based trial (OSTPRE-FPS). Osteoporos Int., 2010; 21(12): Daniele ND, Carbonelli MG, Candeloro N, Iacopino L, Lorenzo AD, Andreoli A. Effect of supplementation of calcium and Vitamin D on bone mineral density and bone mineral Vol 4, Issue 11,

10 content in peri- and post-menopause women, A double-blind, randomized, controlled trial. Pharmacological Research., 2004; 50: Cooper L, Clifton-Bligh PB, Nery ML, Figtree G, Twigg S, Hibbert E, et al. Vitamin D supplementation and bone mineral density in early postmenopausal women. Am J Clin Nutr., 2003; 77(5): Adams JS, Kantorovich V, WU C, Javanbakht M, Hollis W. Resolution of vitamin D insufficiency in osteopenic patients resulted in rapid recovery of bone mineral density. J Clin Endocrinol Metab., 1999; 84(8): Vol 4, Issue 11,

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