This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 (Responsible Party):
Mairead Kiely PhD, University College Cork
ClinicalTrials.gov Identifier:
NCT01349127
First received: April 21, 2011
Last updated: May 2, 2017
Last verified: May 2017
  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
Vitamin D Deficiency Vitamin D Insufficiency Dietary Supplement: 20µg Vitamin D3 Dietary Supplement: 20µg Vitamin D3 + 500 mg Calcium Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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:


Further study details as provided by Mairead Kiely PhD, University College Cork:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Maternal serum iPTH [ Time Frame: 12 weeks ]
    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
Active Comparator: 20µg Vitamin D3
Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).
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
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.
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
Placebo Comparator: Placebo
Arm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).
Dietary Supplement: Placebo
One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:

Responsible Party: Mairead Kiely PhD, Professor of HUman Nutrition, University College Cork
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 2, 2017

Keywords provided by Mairead Kiely PhD, 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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 23, 2017