Vitamin D Supplementation of Lactating Mothers (MAVID)
This study has been completed.
Sponsor:
Children's Memorial Health Institute, Poland
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: December 10, 2012
Last verified: December 2012
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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 urinary calcium, serum intact parathormone [ Time Frame: 3 time points up to 6 months (0-3-6) ] [ 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 ]
| 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 exclusive 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
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, V-ce 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: | December 10, 2012 |
| Health Authority: | Poland: Ethics Committee |
Keywords provided by Children's Memorial Health Institute, Poland:
|
vitamin D 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 May 16, 2013