Vitamin A DeficiencyPhase 2/3NCT02043223
Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit
A Phase 2/3 study testing Vitamin A (<3-day postpartum), Vitamin A (6 wk postpartum) and Vitamin A (<3-day and 6 wk postpartum) in people with Vitamin A Deficiency, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- Vitamin A (<3-day postpartum), Vitamin A (6 wk postpartum) and Vitamin A (<3-day and 6 wk postpartum)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteBangladesh
- Study dates
- Oct 2013to Jul 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women >-18 years of age with low-risk obstetric
Who cannot join
- Pregnant women expecting a multiple birth
- Take vitamin A supplements during postpartum apart from study intervention
- Premature birth
- Newborn babies with birth defects and / or other serious diseases
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
About this study
Official title: Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?
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.
Read the detailed description
The effect will be assessed by the milk and blood.
- Conditions
- Vitamin A Deficiency
- Being tested
- Vitamin A (<3-day postpartum), Vitamin A (6 wk postpartum), Vitamin A (<3-day and 6 wk postpartum), Placebo
- Keywords
- Vitamin A, Breast milk, Postpartum vitamin A supplementation, Infant vaccine response
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A (<3-day postpartum)Dietary supplement
Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum.
Vitamin A (6 wk postpartum)Dietary supplement
Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.
Vitamin A (<3-day and 6 wk postpartum)Dietary supplement
200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum
PlaceboDietary supplement
Placebo supplementation, both at <3-day and 6-wk postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Early postpartum vitamin A suppl. | Experimental | Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum. Receives: Dietary Supplement: Vitamin A (<3-day postpartum) |
| Late postpartum vitamin A suppl. | Experimental | Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum. Receives: Dietary Supplement: Vitamin A (6 wk postpartum) |
| Early & late postpartum vitamin A suppl | Experimental | 200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum Receives: Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum) |
| No postpartum vitamin A suppl. | Experimental | Placebo supplementation, both at <3-day and 6-wk postpartum. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-
- < 3-day postpartum (before 1st dose of supplementation)
- 7 wk postpartum (1wk after 2nd dose of supplementation)
- 15 wk postpartum
Measured: Four months
Secondary outcomes (4)
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-
- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination)
- 15 wk of age (1wk after three doses of pentavalent vaccination)
Measured: 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-
- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination)
- 15 wk of age (1wk after three doses of pentavalent vaccination)
Measured: 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-
- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination)
- 15 wk of age (1wk after three doses of pentavalent vaccination)
Measured: 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-
- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination)
- 15 wk of age (1wk after three doses of pentavalent vaccination)
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Peter Bergman, MD, PhD, Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Shaikh M Ahmad, Ph.D, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043223
- Sponsor's protocol ID
- PR-13060
- Status last verified
- Sep 2016
- First submitted
- 5 Dec 2013
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahmad SM, Hossain MI, Bergman P, Kabir Y, Raqib R. The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial. Trials. 2015 Mar 31;16:129. doi: 10.1186/s13063-015-0654-9.
PubMed 25872802
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?
- ClinicalTrials.gov ID
- NCT02043223
- Acronym / sponsor ID
- PR-13060
- Conditions
- Vitamin A Deficiency
- Keywords
- Vitamin A, Breast milk, Postpartum vitamin A supplementation, Infant vaccine response
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Peter Bergman, MD, PhD, Karolinska University Hospital
- Study start
- Oct 2013
- Primary completion
- Jul 2016 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The effect will be assessed by the milk and blood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early postpartum vitamin A suppl. | Experimental | Dietary Supplement: Vitamin A (<3-day postpartum)Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum. |
| Late postpartum vitamin A suppl. | Experimental | Dietary Supplement: Vitamin A (6 wk postpartum)Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum. |
| Early & late postpartum vitamin A suppl | Experimental | Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum)200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum |
| No postpartum vitamin A suppl. | Experimental | Dietary Supplement: PlaceboPlacebo supplementation, both at <3-day and 6-wk postpartum. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women >-18 years of age with low-risk obstetric
Key exclusion criteria (4 listed)
- Pregnant women expecting a multiple birth
- Take vitamin A supplements during postpartum apart from study intervention
- Premature birth
- Newborn babies with birth defects and / or other serious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A (<3-day postpartum)Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum. | Dietary supplement | Early postpartum vitamin A suppl. |
| Vitamin A (6 wk postpartum)Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum. | Dietary supplement | Late postpartum vitamin A suppl. |
| Vitamin A (<3-day and 6 wk postpartum)200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum | Dietary supplement | Early & late postpartum vitamin A suppl |
| PlaceboPlacebo supplementation, both at <3-day and 6-wk postpartum. | Dietary supplement | No postpartum vitamin A suppl. |
Primary outcome
Breast milk immune regulators
Time frame: Four months
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
4 secondary outcomes
Infant T helper cell immune responses
Time frame: Four months
Infant innate immune responses
Time frame: Four months
Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses
Time frame: Four months
Relative abundance of infant gut microbial community and gut inflammatory markers
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Derived from this study: PubMed 25872802Ahmad SM, Hossain MI, Bergman P, Kabir Y, Raqib R. The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial. Trials. 2015 Mar 31;16:129. doi: 10.1186/s13063-015-0654-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaikh M Ahmad, Ph.D principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin A (<3-day postpartum), Vitamin A (6 wk postpartum) and Vitamin A (<3-day and 6 wk postpartum) in people with Vitamin A Deficiency, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk immune regulators (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.