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Vitamin D Supplementation of Lactating Mothers (MAVID)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01506557
First Posted: January 10, 2012
Last Update Posted: July 23, 2013
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.
Collaborator:
Nutricia Research Fundation
Information provided by (Responsible Party):
Justyna Czech-Kowalska, Children's Memorial Health Institute, Poland
  Purpose

The investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both.

The investigators also want to confirm that vitamin D supplementation of exclusively breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status independently of mother's vitamin D supplementation up to 1200 ID/d.

Additionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin D status of pregnant women at the delivery and their newborn infants.


Condition Intervention Phase
Vitamin D Deficiency Dietary Supplement: cholecalciferol Dietary Supplement: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.

Resource links provided by NLM:


Further study details as provided by Justyna Czech-Kowalska, Children's Memorial Health Institute, Poland:

Primary Outcome Measures:
  • serum 25-hydroxyvitamin D concentration, [ Time Frame: 3 time poits up to 6 months (0-3-6 months) ]

Secondary Outcome Measures:
  • body composition measured by dual x-ray densitometry [ Time Frame: 3 time points up to 6 months (0-3-6months) ]
  • serum calcium [ Time Frame: 2 time poits up to 6 months ( 3-6 months) ]
  • calciuria (Urinary calcium and creatinine - UCa/crea) [ Time Frame: 2 time poits up to 6 months ( 3-6 months) ]
  • iPTH [ Time Frame: 3 time poits up to 6 months (0-3-6 months) ]
  • Prevalence of vitamin D deficiency (25OHD<20ng/ml) [ Time Frame: 3 time poits up to 6 months (0-3-6 months) ]
  • Prevalence of vitamin D sufficiency (25OHD>30ng/ml) [ Time Frame: 3 time poits up to 6 months (0-3-6 months) ]

Enrollment: 174
Study Start Date: March 2011
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: choecalciferol Dietary Supplement: cholecalciferol
dose 800 IU/day for 6 month
Other Name: vit D
Placebo Comparator: placebo Dietary Supplement: placebo
oil capsules

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem

Exclusion Criteria:

  • Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.
  • Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506557


Locations
Poland
Public Hospital
Otwock, Warsaw, Poland, 05-400
Anna Mazowiecka Hospital, Warsaw Medical University
Warsaw, Poland, 00-315
Gynecological and Obstetric Hospital
Warsaw, Poland, 02-544
The Children's Memorial Health Institute
Warsaw, Poland, 04-730
Międzyleski Hospital,
Warsaw, Poland, 04-749
Sponsors and Collaborators
Children's Memorial Health Institute, Poland
Nutricia Research Fundation
Investigators
Principal Investigator: Justyna Czech-Kowalska, MD, PhD The Children's Memorial Health Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Justyna Czech-Kowalska, Deputy Head of Neonatology and Intensive Care, MD, PhD, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier: NCT01506557     History of Changes
Other Study ID Numbers: 763/10
First Submitted: May 11, 2011
First Posted: January 10, 2012
Last Update Posted: July 23, 2013
Last Verified: July 2013

Keywords provided by Justyna Czech-Kowalska, Children's Memorial Health Institute, Poland:
vitamin D
vitamin D deficiency
breastfeeding
body composition
bone mineral content

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents