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Completed

NCT Number: NCT01506557

Vitamin D Supplementation of Lactating Mothers

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.

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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

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Public Hospital, Otwock, Warsaw, Poland

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Cholecalciferol

Dietary Supplement

dose 800 IU/day for 6 month

Other names: vit D

Placebo

Dietary Supplement

oil capsules

Primary outcomes

  1. serum 25-hydroxyvitamin D concentration,

    Time frame: 3 time poits up to 6 months (0-3-6 months)

Secondary outcomes

  1. body composition measured by dual x-ray densitometry

    Time frame: 3 time points up to 6 months (0-3-6months)

  2. serum calcium

    Time frame: 2 time poits up to 6 months ( 3-6 months)

  3. calciuria (Urinary calcium and creatinine - UCa/crea)

    Time frame: 2 time poits up to 6 months ( 3-6 months)

  4. iPTH

    Time frame: 3 time poits up to 6 months (0-3-6 months)

  5. Prevalence of vitamin D deficiency (25OHD<20ng/ml)

    Time frame: 3 time poits up to 6 months (0-3-6 months)

  6. Prevalence of vitamin D sufficiency (25OHD>30ng/ml)

    Time frame: 3 time poits up to 6 months (0-3-6 months)

Sponsors and collaborators

Lead sponsor

Children's Memorial Health Institute, Poland

Other

Collaborators

  • Nutricia Research Fundation

Registry information

Official study title

Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.

Acronym: MAVID

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 10, 2012
Registry last updated
Jul 23, 2013

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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