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Vitamin D DeficiencyDMUMsNCT01349127

Trial to Assess Vitamin D Requirements in Lactating Women

A study testing 20µg Vitamin D3 and 20µg Vitamin D3 + 500 mg Calcium in people with Vitamin D Deficiency and Vitamin D Insufficiency, run by University College Cork at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Vitamin D Deficiency, Vitamin D Insufficiency
What is being tested?
20µg Vitamin D3 and 20µg Vitamin D3 + 500 mg Calcium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
1 siteIreland
Study dates
Aug 2008to Dec 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Mothers with diagnosed intestinal malabsorption conditions
  • Mothers with multiple fetuses (e.g. twins)
  • Consumption of medications known to interfere with vitamin D metabolism.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

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

    Cork

Other trials in Ireland

About this study

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

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.

Being tested
20µg Vitamin D3, 20µg Vitamin D3 + 500 mg Calcium, Placebo
Keywords
Vitamin D, Cholecalciferol, Nutrient requirements, Randomised Controlled Trial, Lactation, pregnancy, Cord blood, Human milk, serum 25-hydroxyvitamin D, deficiency, insufficiency, nutrition
Medical subject headings
Vitamin D Deficiency, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20µg Vitamin D3Dietary supplement

    Also called Cholecalciferol

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

  • 20µg Vitamin D3 + 500 mg CalciumDietary supplement

    Also called Cholecalciferol and Calcium

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

  • PlaceboDietary supplement

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

Study groups in NCT01349127
Study groupRoleWhat they receive
20µg Vitamin D3Active comparatorArm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).
Receives: Dietary Supplement: 20µg Vitamin D3
20µg Vitamin D3 + 500 mg CalciumActive comparatorArm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol) and one tablet of calcium carbonate containing 500mg of calcium.
Receives: Dietary Supplement: 20µg Vitamin D3 + 500 mg Calcium
PlaceboPlacebo comparatorArm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 weeks

Secondary outcomes (1)

  1. Maternal serum iPTH

    Baseline and endpoint PTH will be measured in mothers

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2011 (estimated)
  2. Study startAug 2008
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01349127
Sponsor's protocol ID
Cork Vitamin D 06/RD/C/533
Acronym
DMUMs
Status last verified
May 2017
First submitted
21 Apr 2011
Last updated
4 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20089776

  • 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.

    PubMed 19436930

  • 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.

    PubMed 19297462

  • 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.

    PubMed 19064513

  • 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.

    PubMed 18990953

  • 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.

    PubMed 18453316

  • 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.

    PubMed 18400729

  • 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.

    PubMed 18197989

  • 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.

    PubMed 17440527

  • 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.

    PubMed 16872022

  • 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.

    PubMed 16571177

  • 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.

    PubMed 16548220

  • 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.

    PubMed 15714215

  • 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.

    PubMed 15674302

  • 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.

    PubMed 15138462

Questions about this trial

What is this clinical trial studying?

A study testing 20µg Vitamin D3 and 20µg Vitamin D3 + 500 mg Calcium in people with Vitamin D Deficiency and Vitamin D Insufficiency, run by University College Cork at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum 25-hydroxyvitamin D in mothers and levels of vitamin D in maternal milk (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01349127, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.

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