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| Name | Class |
|---|---|
| Nutricia Research Fundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| choecalciferol | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Dietary Supplement | dose 800 IU/day for 6 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum 25-hydroxyvitamin D concentration, | 3 time poits up to 6 months (0-3-6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| body composition measured by dual x-ray densitometry | 3 time points up to 6 months (0-3-6months) | |
| serum calcium | 2 time poits up to 6 months ( 3-6 months) | |
| calciuria (Urinary calcium and creatinine - UCa/crea) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justyna Czech-Kowalska, MD, PhD | The Children's Memorial Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Hospital | Otwock | Warsaw | 05-400 | Poland | ||
| Anna Mazowiecka Hospital, Warsaw Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25232839 | Derived | Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Pludowski P, Wygledowska G, Chazan B, Pawlus B, Zochowska A, Borszewska-Kornacka MK, Karczmarewicz E, Czekuc-Kryskiewicz E, Dobrzanska A. Impact of vitamin D supplementation during lactation on vitamin D status and body composition of mother-infant pairs: a MAVID randomized controlled trial. PLoS One. 2014 Sep 18;9(9):e107708. doi: 10.1371/journal.pone.0107708. eCollection 2014. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| placebo | Dietary Supplement | oil capsules |
|
| 2 time poits up to 6 months ( 3-6 months) |
| iPTH | 3 time poits up to 6 months (0-3-6 months) |
| Prevalence of vitamin D deficiency (25OHD<20ng/ml) | 3 time poits up to 6 months (0-3-6 months) |
| Prevalence of vitamin D sufficiency (25OHD>30ng/ml) | 3 time poits up to 6 months (0-3-6 months) |
| Warsaw |
| 00-315 |
| Poland |
| Gynecological and Obstetric Hospital | Warsaw | 02-544 | Poland |
| The Children's Memorial Health Institute | Warsaw | 04-730 | Poland |
| Międzyleski Hospital, | Warsaw | 04-749 | Poland |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |