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| Name | Class |
|---|---|
| Queen Sirikit National Institute of Child Health | OTHER_GOV |
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This randomized, placebo-controlled trial in Thai pregnancy is conducted. The study aims to determine whether vitamin D3 1,800 IU/d supplementation in lactating mother improves vitamin D status of breastfed infant.
Vitamin D deficiency in pregnancy increases risk of gestational diabetes mellitus, pre-eclampsia, preterm birth, low birth weight and cesarean section. To against these adverse events, vitamin D supplementation in pregnancy and lactation is recommended, but dose ranges are varied. Then, this study is carried out in lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester. Subjects are divided into 2 groups, one is randomly assigned to 1,800 IU/d compared with maternal and infant controls receiving placebo. Maternal serum 25OHD and milk VitD will be measured by LC-MS/MS during lactation, and on cord blood at 6 weeks breastfed infants. This study is submitted for ethical consideration by relevant Ethics committee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calciferol,1800 IU/d supplement | Active Comparator | The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to 1,800 IU/d . |
|
| Placebo | Placebo Comparator | The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calciferol | Drug | Comparison 25OHD levels between calciferol and placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison serum 25OHD levels from breastfed infants | 6 weeks after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sathit Niramitmahapanya, MD | Department of Medical Services Ministry of Public Health of Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
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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 | Drug |
|
| 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 |