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The purpose of this study is to determine whether a daily supplement of vitamin D, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol (Vitamin D3) 35 µg | Active Comparator | Dietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day |
|
| Cholecalciferol (Vitamin D3) 70 µg | Active Comparator | Dietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol 35 µg per day | Dietary Supplement | Cholecalciferol (Vitamin D3) oral 1 tablet 35 µg per day. Placebo oral 1 tablet per day. In total 35 µg per day. In total 2 tablets per day per participant from Baseline to 16 weeks after delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Birth Weight | 0-24 hours after delivery of the child |
| Measure | Description | Time Frame |
|---|---|---|
| Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD). | Day 1 to 4 months after delivery. | |
| Infections of the newborn | Day 1 of the child to 16 weeks after birth. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gitte Bloch Rasmussen, MD | Contact | +45 89 4976 81 | gittebr@ki.au.dk | |
| Lars Rejnmark, MD, PhD, DrMed | Contact | rejnmark@post6.tele.dk |
| Name | Affiliation | Role |
|---|---|---|
| Gitte Bloch Rasmussen, MD | Aarhus University Hospital | Principal Investigator |
| Lars Rejnmark, MD, PhD, Drmed. | Aarhus University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Aarhus, Aarhus Universityhospital | Recruiting | Aarhus | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39077939 | Derived | Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 13, 2016 | |
| Reset | Jun 20, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 13, 2016 | Jun 20, 2016 |
| ID | Term |
|---|---|
| D001724 | Birth Weight |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001361 | Avitaminosis |
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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 tablet | Other | placebo 2 tablet, once a day, |
|
| Cholecalciferol (Vitamin D3) 70 µg | Dietary Supplement | Cholecalciferol (Vitamin D3) oral 2 tablets each containing 35 µg. In total 70 µg per day. In total 2 tablets per day per participant from Baseline to 16 weeks after delivery. |
|
| Growth of the newborn measured by weight, crown-heel length and head circumference |
| Day 1 of the child to 16 weeks after birth |
| Time to accomplish pregnancy | 0-12 months |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |