NCT01349127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

April 21, 2011

Last Update Submit

May 2, 2017

Conditions

Vitamin D DeficiencyVitamin D Insufficiency

Keywords

Vitamin DCholecalciferolNutrient requirementsRandomised Controlled TrialLactationpregnancyCord bloodHuman milkserum 25-hydroxyvitamin Ddeficiencyinsufficiencynutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Maternal serum iPTH

    12 weeks

Study Arms (3)

20µg Vitamin D3

ACTIVE COMPARATOR

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

Dietary Supplement: 20µg Vitamin D3

20µg Vitamin D3 + 500 mg Calcium

ACTIVE COMPARATOR

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.

Dietary Supplement: 20µg Vitamin D3 + 500 mg Calcium

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

20µg Vitamin D3DIETARY_SUPPLEMENT

20µg (800IU) of vitamin D3/day for 12-weeks while lactating, commencing 10-14 days post-partum.

Also known as: Cholecalciferol
20µg Vitamin D3
20µg Vitamin D3 + 500 mg CalciumDIETARY_SUPPLEMENT

20µg (800IU) of vitamin D3 + 500mg calcium carbonate/day for 12-weeks while lactating, commencing 10-14 days post-partum.

Also known as: Cholecalciferol and Calcium
20µg Vitamin D3 + 500 mg Calcium
PlaceboDIETARY_SUPPLEMENT

One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Food & Nutritional Sciences, University College Cork,

Cork, Ireland

Location

Related Publications (18)

  • 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.

    PMID: 20089776BACKGROUND

  • 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.

    PMID: 19436930BACKGROUND

  • 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.

    PMID: 19297462BACKGROUND

  • 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.

    PMID: 19064513BACKGROUND

  • 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.

    PMID: 18990953BACKGROUND

  • 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.

    PMID: 18453316BACKGROUND

  • 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.

    PMID: 18400729BACKGROUND

  • 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.

    PMID: 18197989BACKGROUND

  • 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.

    PMID: 17440527BACKGROUND

  • 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.

    PMID: 16872022BACKGROUND

  • 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.

    PMID: 16571177BACKGROUND

  • 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.

    PMID: 16548220BACKGROUND

  • 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.

    PMID: 15714215BACKGROUND

  • 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.

    PMID: 15674302BACKGROUND

  • 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.

    PMID: 15138462BACKGROUND

  • 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.

    PMID: 21474925BACKGROUND

  • 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.

    PMID: 21270359BACKGROUND

  • 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.

    PMID: 21118613BACKGROUND

Related Links

MeSH Terms

Conditions

Vitamin D DeficiencyBreast Feeding

Interventions

CholecalciferolCalcium

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Mairead E Kiely, PhD

    University College Cork

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of HUman Nutrition

Study Record Dates

First Submitted

April 21, 2011

First Posted

May 6, 2011

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

IE(1)