Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial (AViDD-2)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01126528 |
|
Recruitment Status
:
Completed
First Posted
: May 19, 2010
Last Update Posted
: August 17, 2012
|
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 18, 2010 | |||||||||
| First Posted Date ICMJE | May 19, 2010 | |||||||||
| Last Update Posted Date | August 17, 2012 | |||||||||
| Study Start Date ICMJE | August 2010 | |||||||||
| Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Serum 25-hydroxyvitamin D concentration [ Time Frame: Maternal: during 3rd trimester; Neonatal (cord blood) ] Biomarker of vitamin D status.
|
|||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT01126528 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
|||||||||
| Original Secondary Outcome Measures ICMJE |
|
|||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial | |||||||||
| Official Title ICMJE | The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh | |||||||||
| Brief Summary | This study is a randomized placebo-controlled trial of oral weekly vitamin D3 (cholecalciferol) supplementation during the third trimester of pregnancy among women in Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence that improving vitamin D status among pregnant women in Bangladesh will enhance the resistance of the infant offspring to infection. The aims of the study are to assess the effect of supplementation on 1) maternal and infant vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of neonatal immune function. |
|||||||||
| Detailed Description | The primary aims of this study are: AIM #1 - To assess the effect of weekly antenatal administration of oral vitamin D3 (875 mcg/week = 35,000 IU week ≈ 5,000 IU per day) started in the third trimester (26-29 weeks gestation) on maternal vitamin D status and fetal-neonatal vitamin D status (cord blood), in comparison to a placebo control supplement. AIM #2 - To demonstrate the maternal and fetal safety of weekly maternal antenatal (second and third-trimester) vitamin D supplementation at a dose of 875 mcg/week by monitoring maternal serum calcium, urinary calcium excretion, cord blood calcium concentration, and newborn clinical parameters. AIM #3 - To measure the effect of antenatal vitamin D supplementation on selected biomarkers of fetal-neonatal immune function in cord blood: in vitro stimulated cord blood mononuclear cell (CBMC) LL-37 expression, gene expression related to inflammatory and immunoregulatory pathways, Th1/Th2 cytokine secretion, and bactericidal properties. |
|||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase | Phase 2 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
|||||||||
| Condition ICMJE | Pregnancy | |||||||||
| Intervention ICMJE |
|
|||||||||
| Study Arms |
|
|||||||||
| Publications * |
|
|||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
160 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date | May 2012 | |||||||||
| Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
| Sex/Gender |
|
|||||||||
| Ages | 18 Years to 34 Years (Adult) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Bangladesh | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01126528 | |||||||||
| Other Study ID Numbers ICMJE | JHU-IRB2481 02829-5 ( Other Grant/Funding Number: Thrasher Research Fund ) |
|||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health | |||||||||
| Study Sponsor ICMJE | Johns Hopkins Bloomberg School of Public Health | |||||||||
| Collaborators ICMJE | International Centre for Diarrhoeal Disease Research, Bangladesh | |||||||||
| Investigators ICMJE |
|
|||||||||
| PRS Account | Johns Hopkins Bloomberg School of Public Health | |||||||||
| Verification Date | August 2012 | |||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||||||||