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Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.
Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage.
Investigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 IU Vitamin D3 | Active Comparator | 400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery. |
|
| 4000 IU Vitamin D3 | Experimental | 4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 IU Vitamin D3 | Drug | Antenatal multivitamin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pre-eclampsia in Both Arms | Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose. | From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vitamin D Level | Level of Improvement in Vitamin D status in both arms | At 36th week of pregnancy |
| Number of Patients With Intrauterine Growth Retardation | Patients having fetus with retardation of growth in both arms. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant population
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416 participants were screened. 192 did not meet eligibility criteria. 38 refused to participate and 7 turned out to be ectopic pregnancy.
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| ID | Title | Description |
|---|---|---|
| FG000 | 400 IU | Materna tablet once daily orally from 14 weeks of pregnancy til delivery. |
| FG001 | 4000 IU | Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 400 IU Vitamin D3 | 400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery. 400 IU Vitamin D3: Antenatal multivitamin |
| BG001 | 4000 IU Vitamin D3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Pre-eclampsia in Both Arms | Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose. | Posted | Count of Participants | Participants | From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 400 IU | Materna tablet once daily orally from 14 weeks of pregnancy til delivery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Consultant Obstetritian and Gynecologist | King Fahd Medical City | 00966539417217 | amali@kfmc.med.sa |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D011225 | Pre-Eclampsia |
| 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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| 4000 IU Vitamin D3 | Drug | 4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily |
|
|
| At delivery |
4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.
4000 IU Vitamin D3: 4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m2 |
|
| Primiparity | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Change in Vitamin D Level | Level of Improvement in Vitamin D status in both arms | Out of 86 participants randomized for the arm of 400 IU, 3 had miscarriage and 2 lost to follow. So 81 participants were analyzed. Out of 93 participants randomized for the arm of 4000 IU, 6 had miscarriage and 4 lost to follow. So 83 were analyzed in that arm. | Posted | Mean | Standard Deviation | nmol/L | At 36th week of pregnancy |
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|
|
| Secondary | Number of Patients With Intrauterine Growth Retardation | Patients having fetus with retardation of growth in both arms. | Posted | Count of Participants | Participants | At delivery |
|
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | 4000 IU | Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery. | 0 | 93 | 0 | 93 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |