Trial to Assess Vitamin D Requirements in Lactating Women

Vitamin D Deficiency Clinical Trial

— DMUMs  

Official title:

Randomised Placebo-controlled Supplementation Study With Vitamin D and Calcium in Breastfeeding Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349127
• Other study ID #: Cork Vitamin D 06/RD/C/533
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: May 2, 2017
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2017
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, placebo-controlled trial of vitamin D supplementation with 20mcg cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to assess vitamin D requirements in lactating women and to ascertain whether vitamin D supplementation at levels sufficient to achieve defined thresholds of maternal serum 25-hydroxyvitamin D will increase the vitamin D content of maternal milk. The study will also report serum 25-hydroxyvitamin D in maternal-cord dyads over a 12-month period and describe the relationship between them. Information on maternal iPTH levels, anthropometry, diet and sun exposure will also be reported.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women intending to breast feed their infant for at least 12-weeks

• Pregnant women >20 weeks gestation

• Pregnant women >18 years of age

• Pregnant women in good general health

Exclusion Criteria:

• Consumption of a vitamin D-containing supplement(>10µg/day) in the 3 months prior to commencing the trial

• 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.

Related Conditions & MeSH terms

• Vitamin D Deficiency
• Vitamin D Insufficiency

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Ireland	School of Food & Nutritional Sciences, University College Cork,	Cork

Sponsors (2)

Lead Sponsor	Collaborator
University College Cork	Irish Government Department of Agriculture, Food and Fisheries, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (18)

Andersen R, Mølgaard C, Skovgaard LT, Brot C, Cashman KD, Chabros E, Charzewska J, Flynn A, Jakobsen J, Kärkkäinen 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. — View Citation

Andersen R, Mølgaard 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. Epub 2007 Apr 18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25-hydroxyvitamin D in mothers and levels of vitamin D in maternal milk	Baseline and endpoint serum 25(OH)D analysis in mothers (week 0 and week 12); baseline, week 4, week 8 and enpoint analysis of vitamin D3, D2 and 25(OH)D in expressed breast milk (hindmilk samples)	12 weeks
Secondary	Maternal serum iPTH	Baseline and endpoint PTH will be measured in mothers	12 weeks

External Links

•   Vitamin D Research group at University College Cork