Trial to Assess Vitamin D Requirements in Lactating Women
NCT ID: NCT01349127
Last Updated: 2017-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2008-08-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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20µg Vitamin D3
Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).
20µg Vitamin D3
20µg (800IU) of vitamin D3/day for 12-weeks while lactating, commencing 10-14 days post-partum.
20µg Vitamin D3 + 500 mg Calcium
Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol) and one tablet of calcium carbonate containing 500mg of calcium.
20µg Vitamin D3 + 500 mg Calcium
20µg (800IU) of vitamin D3 + 500mg calcium carbonate/day for 12-weeks while lactating, commencing 10-14 days post-partum.
Placebo
Arm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).
Placebo
One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.
Interventions
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20µg Vitamin D3
20µg (800IU) of vitamin D3/day for 12-weeks while lactating, commencing 10-14 days post-partum.
20µg Vitamin D3 + 500 mg Calcium
20µg (800IU) of vitamin D3 + 500mg calcium carbonate/day for 12-weeks while lactating, commencing 10-14 days post-partum.
Placebo
One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pregnant women \>20 weeks gestation
* Pregnant women \>18 years of age
* Pregnant women in good general health
Exclusion Criteria
* Consumption of a vitamin D or calcium containing supplement during the 12- week trial
* Mothers taking a vacation to a sunny climate or using a solarium during the 12-week trial
* Mothers with pre-existing type 1 or type 2 diabetes
* Mothers with pre-existing hypertension
* Mothers with diagnosed hypercalcemia
* Mothers with diagnosed intestinal malabsorption conditions
* Mothers with multiple fetuses (e.g. twins)
* Consumption of medications known to interfere with vitamin D metabolism.
18 Years
FEMALE
Yes
Sponsors
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Irish Government Department of Agriculture, Food and Fisheries, Ireland
UNKNOWN
University College Cork
OTHER
Responsible Party
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Mairead Kiely PhD
Professor of HUman Nutrition
Principal Investigators
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Mairead E Kiely, PhD
Role: PRINCIPAL_INVESTIGATOR
University College Cork
Locations
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School of Food & Nutritional Sciences, University College Cork,
Cork, , Ireland
Countries
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References
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Seamans KM, Hill TR, Wallace JM, Horigan G, Lucey AJ, Barnes MS, Taylor N, Bonham MP, Muldowney S, Duffy EM, Strain JJ, Kiely M, Cashman KD. Cholecalciferol supplementation throughout winter does not affect markers of bone turnover in healthy young and elderly adults. J Nutr. 2010 Mar;140(3):454-60. doi: 10.3945/jn.109.113480. Epub 2010 Jan 20.
Hill TR, Cotter AA, Mitchell S, Boreham CA, Dubitzky W, Murray L, Strain JJ, Flynn A, Robson PJ, Wallace JM, Kiely M, Cashman KD. Vitamin D status and parathyroid hormone relationship in adolescents and its association with bone health parameters: analysis of the Northern Ireland Young Heart's Project. Osteoporos Int. 2010 Apr;21(4):695-700. doi: 10.1007/s00198-009-0959-1. Epub 2009 May 13.
Cashman KD, Wallace JM, Horigan G, Hill TR, Barnes MS, Lucey AJ, Bonham MP, Taylor N, Duffy EM, Seamans K, Muldowney S, Fitzgerald AP, Flynn A, Strain JJ, Kiely M. Estimation of the dietary requirement for vitamin D in free-living adults >=64 y of age. Am J Clin Nutr. 2009 May;89(5):1366-74. doi: 10.3945/ajcn.2008.27334. Epub 2009 Mar 18.
Cashman KD, Hill TR, Lucey AJ, Taylor N, Seamans KM, Muldowney S, Fitzgerald AP, Flynn A, Barnes MS, Horigan G, Bonham MP, Duffy EM, Strain JJ, Wallace JM, Kiely M. Estimation of the dietary requirement for vitamin D in healthy adults. Am J Clin Nutr. 2008 Dec;88(6):1535-42. doi: 10.3945/ajcn.2008.26594.
O'Riordan MN, Kiely M, Higgins JR, Cashman KD. Prevalence of suboptimal vitamin D status during pregnancy. Ir Med J. 2008 Sep;101(8):240, 242-3.
Hill TR, McCarthy D, Jakobsen J, Lamberg-Allardt C, Kiely M, Cashman KD. Seasonal changes in vitamin D status and bone turnover in healthy Irish postmenopausal women. Int J Vitam Nutr Res. 2007 Sep;77(5):320-5. doi: 10.1024/0300-9831.77.5.320.
Cashman KD, Hill TR, Cotter AA, Boreham CA, Dubitzky W, Murray L, Strain J, Flynn A, Robson PJ, Wallace JM, Kiely M. Low vitamin D status adversely affects bone health parameters in adolescents. Am J Clin Nutr. 2008 Apr;87(4):1039-44. doi: 10.1093/ajcn/87.4.1039.
Hill TR, Cotter AA, Mitchell S, Boreham CA, Dubitzky W, Murray L, Strain JJ, Flynn A, Robson PJ, Wallace JM, Kiely M, Cashman KD. Vitamin D status and its determinants in adolescents from the Northern Ireland Young Hearts 2000 cohort. Br J Nutr. 2008 May;99(5):1061-7. doi: 10.1017/S0007114507842826. Epub 2008 Jan 15.
Andersen R, Molgaard C, Skovgaard LT, Brot C, Cashman KD, Jakobsen J, Lamberg-Allardt C, Ovesen L. Pakistani immigrant children and adults in Denmark have severely low vitamin D status. Eur J Clin Nutr. 2008 May;62(5):625-34. doi: 10.1038/sj.ejcn.1602753. Epub 2007 Apr 18.
McCarthy D, Collins A, O'Brien M, Lamberg-Allardt C, Jakobsen J, Charzewska J, Kiely M, Flynn A, Cashman KD. Vitamin D intake and status in Irish elderly women and adolescent girls. Ir J Med Sci. 2006 Apr-Jun;175(2):14-20. doi: 10.1007/BF03167942.
Hill TR, O'Brien MM, Lamberg-Allardt C, Jakobsen J, Kiely M, Flynn A, Cashman KD. Vitamin D status of 51-75-year-old Irish women: its determinants and impact on biochemical indices of bone turnover. Public Health Nutr. 2006 Apr;9(2):225-33. doi: 10.1079/phn2005837.
Hill TR, Flynn A, Kiely M, Cashman KD. Prevalence of suboptimal vitamin D status in young, adult and elderly Irish subjects. Ir Med J. 2006 Feb;99(2):48-9.
Andersen R, Molgaard C, Skovgaard LT, Brot C, Cashman KD, Chabros E, Charzewska J, Flynn A, Jakobsen J, Karkkainen M, Kiely M, Lamberg-Allardt C, Moreiras O, Natri AM, O'brien M, Rogalska-Niedzwiedz M, Ovesen L. Teenage girls and elderly women living in northern Europe have low winter vitamin D status. Eur J Clin Nutr. 2005 Apr;59(4):533-41. doi: 10.1038/sj.ejcn.1602108.
Hill T, Collins A, O'Brien M, Kiely M, Flynn A, Cashman KD. Vitamin D intake and status in Irish postmenopausal women. Eur J Clin Nutr. 2005 Mar;59(3):404-10. doi: 10.1038/sj.ejcn.1602088.
Hill TR, O'brien MM, Cashman KD, Flynn A, Kiely M. Vitamin D intakes in 18-64-y-old Irish adults. Eur J Clin Nutr. 2004 Nov;58(11):1509-17. doi: 10.1038/sj.ejcn.1602001.
Muldowney S, Lucey AJ, Paschos G, Martinez JA, Bandarra N, Thorsdottir I, Cashman KD, Kiely M. Relationships between vitamin D status and cardio-metabolic risk factors in young European adults. Ann Nutr Metab. 2011;58(2):85-93. doi: 10.1159/000324600. Epub 2011 Apr 8.
Barnes MS, Horigan G, Cashman KD, Hill TR, Forsythe LK, Lucey AJ, McSorley EM, Kiely M, Bonham MP, Magee PJ, Strain JJ, Wallace JM. Maintenance of wintertime vitamin D status with cholecalciferol supplementation is not associated with alterations in serum cytokine concentrations among apparently healthy younger or older adults. J Nutr. 2011 Mar;141(3):476-81. doi: 10.3945/jn.110.131516. Epub 2011 Jan 26.
Muldowney S, Kiely M. Vitamin D and cardiometabolic health: a review of the evidence. Nutr Res Rev. 2011 Jun;24(1):1-20. doi: 10.1017/S0954422410000259. Epub 2010 Dec 1.
Related Links
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Vitamin D Research group at University College Cork
Other Identifiers
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Cork Vitamin D 06/RD/C/533
Identifier Type: -
Identifier Source: org_study_id
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