A Phase 2/3 interventional study of Vitamin A (<3-day postpartum) and Vitamin A (6 wk postpartum) in Vitamin A Deficiency, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 1 site in Bangladesh. Open to female participants aged 18 Years to 32 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-21.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Phase 2/3, Interventional, and Prevention
Among 10 studies testing Vitamin A in Vitamin A Deficiency — 2 open to participants now, 2 under way, none of them phase 3. Vitamin A · Vitamin A Deficiency.
Among the 10 studies testing Vitamin A in Vitamin A Deficiency, this one is the 9th largest by enrollment, is the only one that started in 2013, is one of 2 in phase 2/3, and was the 6th registered.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
Browse Vitamin A Deficiency studies →2 of the 10 studies testing Vitamin A in Vitamin A Deficiency are open now, in 2 countries. Recruiting first, the newest first:
Second Affiliated Hospital of Wenzhou Medical University · Sites in China
Ages 6–15
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 18+
By country, each count listing its studies:
Vitamin A: first FDA approval 1953 (M.V.I.-12 ADULT). What it is approved for, and how studies give it, is on its page →
Of the 6 Vitamin A Deficiency studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 32 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 3
First in 1997; this study’s year is marked. 1 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 160 is below the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Median enrollment 350 across the 10 interventional studies. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 10 most frequent:
International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 206 studies on the registry; 31 are open to participants now.
International Centre for Diarrhoeal Disease Research, Bangladesh has 1 study filed under Vitamin A Deficiency — fewer than ten, so there is no comparison to draw.
1 of the studies testing Vitamin A in Vitamin A Deficiency that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06450925Children's Hospital Medical Center, CincinnatiVitamin A Supplementation in Allogeneic Stem Cell Transplantation. | 2027-08 |
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Among the 10 studies testing Vitamin A in Vitamin A Deficiency, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.
The effect will be assessed by the milk and blood.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Single dose 200,000 IU vitamin A supplementation at \<3-day and placebo supplementation at 6-wk postpartum.
Dietary Supplement: Vitamin A (<3-day postpartum)
Placebo supplementation at \<3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.
Dietary Supplement: Vitamin A (6 wk postpartum)
200,000 IU vitamin A supplementation, both at \<3-day and 6-wk postpartum
Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum)
Placebo supplementation, both at \<3-day and 6-wk postpartum.
Dietary Supplement: Placebo
Single dose 200,000 IU vitamin A supplementation at \<3-day and placebo supplementation at 6-wk postpartum.
Placebo supplementation at \<3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.
Drug page: Vitamin A
200,000 IU vitamin A supplementation, both at \<3-day and 6-wk postpartum
Placebo supplementation, both at \<3-day and 6-wk postpartum.
Breast milk immune regulators
immune regulators in breast milk e.g. B-cell activating factor (BAFF); IL-7; Lactoferrin; sCD14, sIgA and TGF-beta levels at three time points- 1. \< 3-day postpartum (before 1st dose of supplementation) 2. 7 wk postpartum (1wk after 2nd dose of supplementation) 3. 15 wk postpartum
Time frame: Four months
Infant T helper cell immune responses
Mitogen stimulated whole blood IL-10, IL-13, IFN-gamma, IL-21 and IL-17 responses at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination)
Time frame: Four months
Infant innate immune responses
Tall like receptor (TLR)-4 and TLR9 agonist stimulated whole blood TNF-alpha and IL-10 and IFN-alpha responses at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination)
Time frame: Four months
Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses
Hepatitis B and Tetanus Toxoid specific plasma cell IgG responses at 15 wk of age (1wk after three doses of pentavalent vaccination) And Hepatitis B and Tetanus Toxoid specific IgG in plasma and Polio (3 serotypes) specific secretory IgA (sIgA) in stool at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination)
Time frame: Four months
Relative abundance of infant gut microbial community and gut inflammatory markers
Next generation sequencing (NGS) of bacterial 16s rDNA (+qPCR) in extracted stool samples and assessment of infant gut inflammatory markers e.g. human β-defensin-2 (HBD2); Neopterin; α-1-antitrypsin (AAT); neutrophil gelatinase-associated lipocalin (NGAL)-2 and S100A at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination)
Time frame: Four months
Infant vitamin A status
Infant plasma vitamin A status at 7 wk and 15 wk of age
Time frame: Four months
Infant growth
Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age
Time frame: Four months
Infant morbidity
Infant morbidity status up to four months of age
Time frame: Four months
Mother vitamin A status
Plasma Retinol Binding Protein (RBP) and breast milk vitamin A level at two time points- 1. \< 3-day postpartum (before 1st dose of supplementation) 2. 15 wk postpartum
Time frame: Four months
The record gives a start of Oct 2013 and a primary completion of Jul 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin A
International Centre for Diarrhoeal Disease Research, Bangladesh →