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Trial to Assess Vitamin D Requirements in Lactating Women

NCT01349127 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2017-05-04

No results posted yet for this study

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.

Conditions

  • Vitamin D Deficiency
  • Vitamin D Insufficiency

Interventions

DIETARY_SUPPLEMENT

20µg Vitamin D3

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

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.

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • University College Cork

    lead OTHER

Principal Investigators

  • Mairead E Kiely, PhD · University College Cork

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349127 on ClinicalTrials.gov