Vitamin D Supplementation of Lactating Mothers (MAVID)

This study has been completed.
Sponsor:
Collaborator:
Nutricia Research Fundation
Information provided by (Responsible Party):
Justyna Czech-Kowalska, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier:
NCT01506557
First received: May 11, 2011
Last updated: July 22, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • body composition measured by dual x-ray densitometry [ Time Frame: 3 time points up to 6 months (0-3-6months) ] [ Designated as safety issue: No ]
  • serum calcium [ Time Frame: 2 time poits up to 6 months ( 3-6 months) ] [ Designated as safety issue: Yes ]
  • calciuria (Urinary calcium and creatinine - UCa/crea) [ Time Frame: 2 time poits up to 6 months ( 3-6 months) ] [ Designated as safety issue: Yes ]
  • iPTH [ Time Frame: 3 time poits up to 6 months (0-3-6 months) ] [ Designated as safety issue: No ]
  • Prevalence of vitamin D deficiency (25OHD<20ng/ml) [ Time Frame: 3 time poits up to 6 months (0-3-6 months) ] [ Designated as safety issue: No ]
  • Prevalence of vitamin D sufficiency (25OHD>30ng/ml) [ Time Frame: 3 time poits up to 6 months (0-3-6 months) ] [ Designated as safety issue: No ]

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

Genders 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
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: NCT01506557

Locations
Poland
Public Hospital
Otwock, Warsaw, Poland, 05-400
Anna Mazowiecka Hospital, Warsaw Medical University
Warsaw, Poland, 00-315
Międzyleski Hospital,
Warsaw, Poland, 04-749
Gynecological and Obstetric Hospital
Warsaw, Poland, 02-544
The Children's Memorial Health Institute
Warsaw, Poland, 04-730
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

No publications provided

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
Study First Received: May 11, 2011
Last Updated: July 22, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by 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
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 26, 2014