AnemiaTOPPSNCT01183572
Trial of Pre-Pregnancy Supplements
A study testing Multivitamins, Folic Acid, and Iron, Folic Acid and Iron and Folic Acid in people with Anemia, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
Trial summary
The purpose of this study is to determine whether daily oral supplements of multivitamins (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant women results in lower prevalence of anemia in preparation for pregnancy when compared to daily iron and folic acid supplements or folic… Read more about this study
- Who is it for?
- Ages 15 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Multivitamins, Folic Acid, and Iron, Folic Acid and Iron and Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 802 participants
- Where
- 1 siteTanzania
- Study dates
- Aug 2010to Jan 2012
- Phase
- Interventional
- 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 15 to 29 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Girls aged > =15 years and <= 29 years
- Have not missed a menstrual period during recruitment (no amenorrhea)
- Has not been pregnant or given birth within the last 6 months
- Intend to stay in the study area for at least 6 months after enrollment
- Have provided written informed consent
Who cannot join
- Amenorrhea or confirmed pregnancy at screening or enrollment.
- Has given birth within 6 months
- Already taking long-term vitamin supplementation.
- Any severe illness requiring hospitalization at screening or enrollment (women who have been deemed to have recovered will be eligible once they return home).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether daily oral supplements of multivitamins (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant women results in lower prevalence of anemia in preparation for pregnancy when compared to daily iron and folic acid supplements or folic acid alone.
Read the detailed description
Globally, more than half a million women die from pregnancy or childbirth-related complications, most of them in developing countries. The global community committed to reducing the maternal mortality ratio by three quarters between 1990 and 2015 (MDG5). Women die from a range of complications in pregnancy, childbirth or the postpartum period. 80% of maternal deaths are due to severe bleeding (mostly bleeding postpartum), infections, hypertensive disorders in pregnancy and obstructed labor. Additionally, low birth weight and neonatal mortality are common problems in developing countries. The benefit of periconceptual folate on preventing congenital anomalies has been established in randomized trials; however, the role of other nutrients needs to be examined further. Anemia is strongly associated with adverse perinatal outcomes including maternal mortality and low birthweight.
- Conditions
- Anemia
- Being tested
- Multivitamins, Folic Acid, and Iron, Folic Acid and Iron, Folic Acid
- Keywords
- multivitamins, folate, iron, periconception
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamins, Folic Acid, and IronDietary supplement
Daily oral dose containing 2500 IU Vitamin A, 1.4 mg Vitamin B1, 1.4 mg Vitamin B2, 2.6 mg Vitamin B12, 1.9 mg Vitamin B6, 18 mg Niacin, 70 mg Vitamin C, 14.9 IU Vitamin E, 30 mg elemental iron, 0.4 mg folic acid
Folic Acid and IronDietary supplement
Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid
Folic AcidDietary supplement
Daily oral dose of 0.4 mg folic acid
| Study group | Role | What they receive |
|---|---|---|
| Folic Acid and Iron | Active comparator | 0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months Receives: Dietary Supplement: Folic Acid and Iron |
| Folic Acid | Placebo comparator | 0.4mg of folic acid taken daily for 6 months Receives: Dietary Supplement: Folic Acid |
| Multivitamins, Folic Acid, and Iron | Active comparator | A multivitamin and micronutrient supplement that constitutes 1 RDA of Vitamins A (2500 IU), B1 (1.4 mg), B2 (1.4 mg), B6 (1.9 mg), B12 (2.6 ug), niacin (18 mg), C (70 mg), E (10 mg), and folic acid (0.4 mg)along with 30 mg of elemental iron taken daily for 6 months. Receives: Dietary Supplement: Multivitamins, Folic Acid, and Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
Anemia will be defined as hemoglobin < 12gm/dL at 6 months of intervention. Hemoglobin concentration will also be analyzed as a continuous outcome.
Measured: 6 months following the start of the intervention
Secondary outcomes (3)
Weight Gain during intervention
Weight gain during intervention will be defined as the difference in weight between weight at randomization and weight at 6 months of intervention.
Measured: 6 months following the start of the intervention
Mid Upper Arm Circumference
Measured: 6 months following the start of the intervention
Peripheral malaria parasitemia
Peripheral malaria parasitemia will be defined as fever in the past 72 hours with any malaria parasitemia in peripheral blood.
Measured: 6 months following the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2012
- Study completionJan 2012
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 AnemiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Institute
- Responsible party
- Principal investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, MD, DrPH, Principal investigator, Harvard School of Public Health (HSPH)Honorati M Masanja, PhD, Principal investigator, Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183572
- Sponsor's protocol ID
- 0055/07
- Acronym
- TOPPS
- Status last verified
- Sep 2012
- First submitted
- 13 Aug 2010
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gunaratna NS, Masanja H, Mrema S, Levira F, Spiegelman D, Hertzmark E, Saronga N, Irema K, Shuma M, Elisaria E, Fawzi W. Multivitamin and iron supplementation to prevent periconceptional anemia in rural tanzanian women: a randomized, controlled trial. PLoS One. 2015 Apr 23;10(4):e0121552. doi: 10.1371/journal.pone.0121552. eCollection 2015.
PubMed 25905863
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Pre-Pregnancy Supplements
- ClinicalTrials.gov ID
- NCT01183572
- Acronym / sponsor ID
- TOPPS / 0055/07
- Conditions
- Anemia
- Keywords
- multivitamins, folate, iron, periconception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Ifakara Health Institute
- Study start
- Aug 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Aug 2010 (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 determine whether daily oral supplements of multivitamins (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant women results in lower prevalence of anemia in preparation for pregnancy when compared to daily iron and folic acid supplements or folic acid alone.
Detailed description
Globally, more than half a million women die from pregnancy or childbirth-related complications, most of them in developing countries. The global community committed to reducing the maternal mortality ratio by three quarters between 1990 and 2015 (MDG5). Women die from a range of complications in pregnancy, childbirth or the postpartum period. 80% of maternal deaths are due to severe bleeding (mostly bleeding postpartum), infections, hypertensive disorders in pregnancy and obstructed labor. Additionally, low birth weight and neonatal mortality are common problems in developing countries. The benefit of periconceptual folate on preventing congenital anomalies has been established in randomized trials; however, the role of other nutrients needs to be examined further. Anemia is strongly associated with adverse perinatal outcomes including maternal mortality and low birthweight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Folic Acid and Iron | Active comparator | Dietary Supplement: Folic Acid and Iron0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months |
| Folic Acid | Placebo comparator | Dietary Supplement: Folic Acid0.4mg of folic acid taken daily for 6 months |
| Multivitamins, Folic Acid, and Iron | Active comparator | Dietary Supplement: Multivitamins, Folic Acid, and IronA multivitamin and micronutrient supplement that constitutes 1 RDA of Vitamins A (2500 IU), B1 (1.4 mg), B2 (1.4 mg), B6 (1.9 mg), B12 (2.6 ug), niacin (18 mg), C (70 mg), E (10 mg), and folic acid (0.4 mg)along with 30 mg of elemental iron taken daily for 6 months. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Girls aged > =15 years and <= 29 years
- Have not missed a menstrual period during recruitment (no amenorrhea)
- Has not been pregnant or given birth within the last 6 months
- Intend to stay in the study area for at least 6 months after enrollment
- Have provided written informed consent
Key exclusion criteria (4 listed)
- Amenorrhea or confirmed pregnancy at screening or enrollment.
- Has given birth within 6 months
- Already taking long-term vitamin supplementation.
- Any severe illness requiring hospitalization at screening or enrollment (women who have been deemed to have recovered will be eligible once they return home).
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 |
|---|---|---|
| Multivitamins, Folic Acid, and IronDaily oral dose containing 2500 IU Vitamin A, 1.4 mg Vitamin B1, 1.4 mg Vitamin B2, 2.6 mg Vitamin B12, 1.9 mg Vitamin B6, 18 mg Niacin, 70 mg Vitamin C, 14.9 IU Vitamin E, 30 mg elemental iron, 0.4 mg folic acid | Dietary supplement | Multivitamins, Folic Acid, and Iron |
| Folic Acid and IronDaily oral dose of 30 mg elemental iron, 0.4 mg folic acid | Dietary supplement | Folic Acid and Iron |
| Folic AcidDaily oral dose of 0.4 mg folic acid | Dietary supplement | Folic Acid |
Primary outcome
Anemia
Time frame: 6 months following the start of the intervention
Anemia will be defined as hemoglobin < 12gm/dL at 6 months of intervention. Hemoglobin concentration will also be analyzed as a continuous outcome.
3 secondary outcomes
Weight Gain during intervention
Time frame: 6 months following the start of the intervention
Mid Upper Arm Circumference
Time frame: 6 months following the start of the intervention
Peripheral malaria parasitemia
Time frame: 6 months following the start of the intervention
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 11 Sep 2012.
- Derived from this study: PubMed 25905863Gunaratna NS, Masanja H, Mrema S, Levira F, Spiegelman D, Hertzmark E, Saronga N, Irema K, Shuma M, Elisaria E, Fawzi W. Multivitamin and iron supplementation to prevent periconceptional anemia in rural tanzanian women: a randomized, controlled trial. PLoS One. 2015 Apr 23;10(4):e0121552. doi: 10.1371/journal.pone.0121552. eCollection 2015.
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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.
Wafaie W Fawzi, MD, DrPH principal investigator
Harvard School of Public Health (HSPH)
Honorati M Masanja, PhD principal investigator
Ifakara Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamins, Folic Acid, and Iron, Folic Acid and Iron and Folic Acid in people with Anemia, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
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 5 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 11 Sep 2012. 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 Tanzania. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Anemia (time frame: 6 months following the start of the intervention). 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 NCT01183572, 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 11 Sep 2012.