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Trial to Assess Vitamin D Requirements in Lactating Women (DMUMs)

Primary Purpose

Vitamin D Deficiency, Vitamin D Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
20µg Vitamin D3
20µg Vitamin D3 + 500 mg Calcium
Placebo
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D, Cholecalciferol, Nutrient requirements, Randomised Controlled Trial, Lactation, pregnancy, Cord blood, Human milk, serum 25-hydroxyvitamin D, deficiency, insufficiency, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Food & Nutritional Sciences, University College Cork,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

20µg Vitamin D3

20µg Vitamin D3 + 500 mg Calcium

Placebo

Arm Description

Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).

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.

Arm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Maternal serum iPTH
Baseline and endpoint PTH will be measured in mothers

Full Information

First Posted
April 21, 2011
Last Updated
May 2, 2017
Sponsor
University College Cork
Collaborators
Irish Government Department of Agriculture, Food and Fisheries, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT01349127
Brief Title
Trial to Assess Vitamin D Requirements in Lactating Women
Acronym
DMUMs
Official Title
Randomised Placebo-controlled Supplementation Study With Vitamin D and Calcium in Breastfeeding Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork
Collaborators
Irish Government Department of Agriculture, Food and Fisheries, Ireland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Vitamin D Insufficiency
Keywords
Vitamin D, Cholecalciferol, Nutrient requirements, Randomised Controlled Trial, Lactation, pregnancy, Cord blood, Human milk, serum 25-hydroxyvitamin D, deficiency, insufficiency, nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20µg Vitamin D3
Arm Type
Active Comparator
Arm Description
Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).
Arm Title
20µg Vitamin D3 + 500 mg Calcium
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).
Intervention Type
Dietary Supplement
Intervention Name(s)
20µg Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
20µg (800IU) of vitamin D3/day for 12-weeks while lactating, commencing 10-14 days post-partum.
Intervention Type
Dietary Supplement
Intervention Name(s)
20µg Vitamin D3 + 500 mg Calcium
Other Intervention Name(s)
Cholecalciferol and Calcium
Intervention Description
20µg (800IU) of vitamin D3 + 500mg calcium carbonate/day for 12-weeks while lactating, commencing 10-14 days post-partum.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.
Primary Outcome Measure Information:
Title
Serum 25-hydroxyvitamin D in mothers and levels of vitamin D in maternal milk
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Maternal serum iPTH
Description
Baseline and endpoint PTH will be measured in mothers
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mairead E Kiely, PhD
Organizational Affiliation
University College Cork
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Food & Nutritional Sciences, University College Cork,
City
Cork
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20089776
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.
Results Reference
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PubMed Identifier
19436930
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.
Results Reference
background
PubMed Identifier
19297462
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.
Results Reference
background
PubMed Identifier
19064513
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.
Results Reference
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PubMed Identifier
18990953
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.
Results Reference
background
PubMed Identifier
18453316
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. doi: 10.1024/0300-9831.77.5.320.
Results Reference
background
PubMed Identifier
18400729
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. doi: 10.1093/ajcn/87.4.1039.
Results Reference
background
PubMed Identifier
18197989
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.
Results Reference
background
PubMed Identifier
17440527
Citation
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.
Results Reference
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PubMed Identifier
16872022
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. doi: 10.1007/BF03167942.
Results Reference
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PubMed Identifier
16571177
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. doi: 10.1079/phn2005837.
Results Reference
background
PubMed Identifier
16548220
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.
Results Reference
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PubMed Identifier
15714215
Citation
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.
Results Reference
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PubMed Identifier
15674302
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. doi: 10.1038/sj.ejcn.1602088.
Results Reference
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PubMed Identifier
15138462
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. doi: 10.1038/sj.ejcn.1602001.
Results Reference
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PubMed Identifier
21474925
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.
Results Reference
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PubMed Identifier
21270359
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.
Results Reference
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PubMed Identifier
21118613
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.
Results Reference
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Links:
URL
http://www.ucc.ie/en/vitamind/
Description
Vitamin D Research group at University College Cork

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Trial to Assess Vitamin D Requirements in Lactating Women

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