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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01126528 |
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Date of registration:
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18/05/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial
AViDD-2 |
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Scientific title:
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The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01126528 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Rubhana Raqib, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Centre for Diarrhoeal Disease Research, Bangladesh |
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Name:
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Daniel Roth, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins Bloomberg School of Public Health |
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Name:
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Abdullah Baqui, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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JHSPH; ICDDR,B |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women aged 18 to <35 years.
- Current residence in Dhaka at a fixed address
- Plans to have the delivery performed at the Shimantik maternity center, and to stay
in Dhaka throughout the pregnancy and for at least one month past the date of
delivery.
- Gestational age of 26th to 29th (inclusive), estimated based on the first day of the
last menstrual period (LMP).
Exclusion Criteria:
- Use of any dietary supplement containing more than 400 IU/day (10 mcg/day) of vitamin
D within the month prior to enrolment, or refusal to stop taking supplemental vitamin
D at any dose after enrollment.
- Current use of anti-convulsant or anti-mycobacterial (tuberculosis) medications.
- Severe anemia (hemoglobin concentration < 70 g/L).
- Complicated medical or obstetric history that may increase the risk of preterm birth
or labor/delivery complications, based on self-report or clinical assessment by
physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa,
threatened abortion, hypertension, preeclampsia, preterm labor, or multiple
gestation).
- Prior history of delivery of an infant with a major congenital anomaly, birth
asphyxia, or perinatal death (stillbirth or death within first week of life).
Age minimum:
18 Years
Age maximum:
34 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
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Intervention(s)
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Dietary Supplement: Vitamin D3
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Dietary Supplement: Placebo control
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Primary Outcome(s)
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Serum 25-hydroxyvitamin D concentration
[Time Frame: Maternal: during 3rd trimester; Neonatal (cord blood)]
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Secondary Outcome(s)
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Neonatal immune function
[Time Frame: Cord blood]
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Infant growth
[Time Frame: Postnatal observational follow-up phase]
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Neonatal serum calcium
[Time Frame: 1st week postnatal]
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Serum calcium concentration
[Time Frame: Maternal:3rd trimester; Cord blood.]
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Urine Ca:Cr ration
[Time Frame: Maternal- 3rd trimester]
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Infant and maternal postnatal vitamin D status
[Time Frame: Postnatal observational follow-up phase]
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Secondary ID(s)
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JHU-IRB2481
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02829-5
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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