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

This study has been completed.
Sponsor:
Collaborator:
Irish Government Department of Agriculture, Food and Fisheries, Ireland
Information provided by:
University College Cork
ClinicalTrials.gov Identifier:
NCT01349127
First received: April 21, 2011
Last updated: May 5, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
Vitamin D Insufficiency
 Drug: Cholecalciferol (Vitamin D3)
Drug: Calcium Carbonate
Drug: Placebo - gelatin capsule
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomised Placebo-controlled Supplementation Study With Vitamin D and Calcium in Breastfeeding Mothers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College Cork:

Primary Outcome Measures:
  • Serum 25-hydroxyvitamin D in mothers and levels of vitamin D in maternal milk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Baseline and endpoint PTH will be measured in mothers


Enrollment: 136
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).
 Drug: Cholecalciferol (Vitamin D3)
Once daily, 20µg (800IU) dose of vitamin D3, vitamin D3 is taken for 12-weeks while lactating, commencing 10-14 days post-partum.
Other Name: Vitamin D
Experimental: Vitamin D & 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.
 Drug: Cholecalciferol (Vitamin D3)
Once daily, 20µg (800IU) dose of vitamin D3, vitamin D3 is taken for 12-weeks while lactating, commencing 10-14 days post-partum.
Other Name: Vitamin D
Drug: Calcium Carbonate
Once daily, 500mg dose of calcium in a tablet form, taken for 12-weeks while lactating, commencing 10-14 days post-partum.
Other Name: Calcium
Placebo Comparator: Placebo gelatin capsule
Arm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).
 Drug: Placebo - gelatin capsule
Once daily, one gelatin capsule containing 0µg (0IU) of vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349127

Locations
Ireland
School of Food & Nutritional Sciences, University College Cork,
Cork, Ireland
Sponsors and Collaborators
University College Cork
Irish Government Department of Agriculture, Food and Fisheries, Ireland
Investigators
Principal Investigator: Mairead E Kiely, PhD University College Cork
  More Information

Additional Information:
Vitamin D Research group at University College Cork  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr. Mairead Kiely, University College Cork, Ireland
ClinicalTrials.gov Identifier: NCT01349127     History of Changes
Other Study ID Numbers: Cork Vitamin D 06/RD/C/533
Study First Received: April 21, 2011
Last Updated: May 5, 2011
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by University College Cork:
Vitamin D
Cholecalciferol
Nutrient requirements
Randomised Controlled Trial
Lactation
pregnancy
 Cord blood
Human milk
serum 25-hydroxyvitamin D
deficiency
insufficiency
nutrition

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium, Dietary
Cholecalciferol
Vitamin D
Ergocalciferols
 Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013