Vitamin D Supplementation of Lactating Mothers

Vitamin D Deficiency Clinical Trial

— MAVID  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506557
• Other study ID #: 763/10
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2011
• Last updated: July 22, 2013
• Start date: March 2011
• Est. completion date: November 2012

Study information

• Verified date: July 2013
• Source: Children's Memorial Health Institute, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• cholecalciferol
dose 800 IU/day for 6 month
• placebo
oil capsules

Locations

Country	Name	City	State
Poland	Public Hospital	Otwock	Warsaw
Poland	Anna Mazowiecka Hospital, Warsaw Medical University	Warsaw
Poland	Gynecological and Obstetric Hospital	Warsaw
Poland	Miedzyleski Hospital,	Warsaw
Poland	The Children's Memorial Health Institute	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Children's Memorial Health Institute, Poland	Nutricia Research Fundation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25-hydroxyvitamin D concentration,		3 time poits up to 6 months (0-3-6 months)	Yes
Secondary	body composition measured by dual x-ray densitometry		3 time points up to 6 months (0-3-6months)	No
Secondary	serum calcium		2 time poits up to 6 months ( 3-6 months)	Yes
Secondary	calciuria (Urinary calcium and creatinine - UCa/crea)		2 time poits up to 6 months ( 3-6 months)	Yes
Secondary	iPTH		3 time poits up to 6 months (0-3-6 months)	No
Secondary	Prevalence of vitamin D deficiency (25OHD<20ng/ml)		3 time poits up to 6 months (0-3-6 months)	No
Secondary	Prevalence of vitamin D sufficiency (25OHD>30ng/ml)		3 time poits up to 6 months (0-3-6 months)	No