Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01349127
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
Irish Government Department of Agriculture, Food and Fisheries, Ireland
Information provided by (Responsible Party):
Mairead Kiely PhD, University College Cork

Tracking Information
First Submitted Date  ICMJE April 21, 2011
First Posted Date  ICMJE May 6, 2011
Last Update Posted Date May 4, 2017
Study Start Date  ICMJE August 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
Serum 25-hydroxyvitamin D in mothers and levels of vitamin D in maternal milk [ Time Frame: 12 weeks ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
Maternal serum iPTH [ Time Frame: 12 weeks ]
Baseline and endpoint PTH will be measured in mothers
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Assess Vitamin D Requirements in Lactating Women
Official Title  ICMJE Randomised Placebo-controlled Supplementation Study With Vitamin D and Calcium in Breastfeeding Mothers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Vitamin D Deficiency
  • Vitamin D Insufficiency
Intervention  ICMJE
  • Dietary Supplement: 20µg Vitamin D3
    20µg (800IU) of vitamin D3/day for 12-weeks while lactating, commencing 10-14 days post-partum.
    Other Name: Cholecalciferol
  • Dietary Supplement: 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.
    Other Name: Cholecalciferol and Calcium
  • Dietary Supplement: Placebo
    One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.
Study Arms  ICMJE
  • Active Comparator: 20µg Vitamin D3
    Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).
    Intervention: Dietary Supplement: 20µg Vitamin D3
  • Active Comparator: 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.
    Intervention: Dietary Supplement: 20µg Vitamin D3 + 500 mg Calcium
  • Placebo Comparator: Placebo
    Arm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2011)
136
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01349127
Other Study ID Numbers  ICMJE Cork Vitamin D 06/RD/C/533
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mairead Kiely PhD, University College Cork
Study Sponsor  ICMJE University College Cork
Collaborators  ICMJE Irish Government Department of Agriculture, Food and Fisheries, Ireland
Investigators  ICMJE
Principal Investigator: Mairead E Kiely, PhD University College Cork
PRS Account University College Cork
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP