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Completed

NCT Number: NCT01349127

Trial to Assess Vitamin D Requirements in Lactating Women

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Behavior Breast Feeding Deficiency Diseases Feeding Behavior Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Insufficiency

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Food & Nutritional Sciences, University College Cork,

Cork, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

20µg Vitamin D3

Dietary Supplement

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

Other names: Cholecalciferol

20µg Vitamin D3 + 500 mg Calcium

Dietary Supplement

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

Other names: Cholecalciferol and Calcium

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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 outcomes

  1. Maternal serum iPTH

    Time frame: 12 weeks

    Baseline and endpoint PTH will be measured in mothers

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • Irish Government Department of Agriculture, Food and Fisheries, Ireland

Registry information

Official study title

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

Acronym: DMUMs

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 6, 2011
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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