PregnancyPhase 3NCT00197548
A Trial of Micronutrients and Adverse Pregnancy Outcomes
A Phase 3 study testing Multivitamins-vitamins B-complex, C, and E in people with Pregnancy and Premature Birth, run by Harvard School of Public Health (HSPH).
Trial summary
The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Premature Birth, Infant, Low Birth Weight
- What is being tested?
- Multivitamins-vitamins B-complex, C, and E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,468 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Jul 2006
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV negative
- 12-26 weeks gestational age at screening visit
Who cannot join
None listed.
About this study
The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.
Read the detailed description
Fetal loss, low birth weight and preterm birth are major public health problems worldwide, particularly in developing countries. Birth outcomes are also major predictors of child health and survival in infancy and beyond. The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women. We also aim to determine whether the potentially protective effect of multivitamin supplements on the risks of low birth weight and preterm birth translate into a sustained reduction in infant mortality.
- Being tested
- Multivitamins-vitamins B-complex, C, and E, Placebo
- Keywords
- Women, Pregnancy Outcomes, Nutrition, Vitamins, Tanzania, Maternal and Child Health Outcomes
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamins-vitamins B-complex, C, and EDietary supplement
One daily oral dose of 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 mg of C, and 30 mg of vitamin E from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
PlaceboDietary supplement
One daily oral dose of a placebo pill taken from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Multivitamins | Active comparator | Multivitamins-vitamins B-complex, C, and E Receives: Dietary Supplement: Multivitamins-vitamins B-complex, C, and E |
| Placebo | Placebo comparator | Placebo pill Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal loss, low birth weight and pre-term birth.
Measured: Delivery
Secondary outcomes (1)
Child morbidity and mortality; child growth
Measured: 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2001
- Primary completionDec 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Investigators
- Wafaie W Fawzi, MD,DrPh, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197548
- Sponsor's protocol ID
- HD37701
- Status last verified
- Nov 2010
- First submitted
- 12 Sep 2005
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, Willett WC, Spiegelman D. Vitamins and perinatal outcomes among HIV-negative women in Tanzania. N Engl J Med. 2007 Apr 5;356(14):1423-31. doi: 10.1056/NEJMoa064868.
PubMed 17409323Wang D, Shahab-Ferdows S, Lweno ON, Hampel D, Method B, Yelverton CA, Nguyen CH, Aboud S, Allen LH, Fawzi WW. The effects of prenatal and postnatal high-dose vitamin B-12 supplementation on human milk vitamin B-12: a randomized, double-blind, placebo-controlled trial in Tanzania. Am J Clin Nutr. 2024 Mar;119(3):730-739. doi: 10.1016/j.ajcnut.2023.07.023. Epub 2023 Nov 30.
PubMed 38432714Cliffer I, Darling AM, Madzorera I, Wang D, Perumal N, Wang M, Liu E, Pembe AB, Urassa W, Fawzi WW. Associations of Diet Quality, Socioeconomic Factors, and Nutritional Status with Gestational Weight Gain among Pregnant Women in Dar es Salaam, Tanzania. Curr Dev Nutr. 2023 Feb 4;7(3):100041. doi: 10.1016/j.cdnut.2023.100041. eCollection 2023 Mar.
PubMed 37181931Kamenju P, Madzorera I, Hertzmark E, Urassa W, Fawzi WW. Higher Dietary Intake of Animal Protein Foods in Pregnancy Is Associated with Lower Risk of Adverse Birth Outcomes. J Nutr. 2022 Nov;152(11):2546-2554. doi: 10.1093/jn/nxac183. Epub 2022 Aug 18.
PubMed 36774120Liu E, Wang D, Darling AM, Perumal N, Wang M, Urassa W, Pembe A, Fawzi WW. Multivitamin Supplementation Is Associated with Greater Adequacy of Gestational Weight Gain among Pregnant Women in Tanzania. J Nutr. 2022 Apr 1;152(4):1091-1098. doi: 10.1093/jn/nxab448.
PubMed 34964890Wang D, Natchu UCM, Darling AM, Noor RA, Hertzmark E, Urassa W, Fawzi WW. Effects of prenatal and postnatal maternal multiple micronutrient supplementation on child growth and morbidity in Tanzania: a double-blind, randomized-controlled trial. Int J Epidemiol. 2022 Dec 13;51(6):1761-1774. doi: 10.1093/ije/dyab117.
PubMed 34151973Madzorera I, Isanaka S, Wang M, Msamanga GI, Urassa W, Hertzmark E, Duggan C, Fawzi WW. Maternal dietary diversity and dietary quality scores in relation to adverse birth outcomes in Tanzanian women. Am J Clin Nutr. 2020 Sep 1;112(3):695-706. doi: 10.1093/ajcn/nqaa172.
PubMed 32651998Quinn MK, Smith ER, Williams PL, Urassa W, Shi J, Msamanga G, Fawzi WW, Sudfeld CR. The Effect of Maternal Multiple Micronutrient Supplementation on Female Early Infant Mortality Is Fully Mediated by Increased Gestation Duration and Intrauterine Growth. J Nutr. 2020 Feb 1;150(2):356-363. doi: 10.1093/jn/nxz246.
PubMed 31605616Winje BA, Kvestad I, Krishnamachari S, Manji K, Taneja S, Bellinger DC, Bhandari N, Bisht S, Darling AM, Duggan CP, Fawzi W, Hysing M, Kumar T, Kurpad AV, Sudfeld CR, Svensen E, Thomas S, Strand TA. Does early vitamin B12 supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania. BMJ Open. 2018 Feb 22;8(2):e018962. doi: 10.1136/bmjopen-2017-018962.
PubMed 29472265
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Micronutrients and Adverse Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT00197548
- Acronym / sponsor ID
- HD37701
- Keywords
- Women, Pregnancy Outcomes, Nutrition, Vitamins, Tanzania, Maternal and Child Health Outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,468 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- Aug 2001
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 20 Sep 2005 (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 examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.
Detailed description
Fetal loss, low birth weight and preterm birth are major public health problems worldwide, particularly in developing countries. Birth outcomes are also major predictors of child health and survival in infancy and beyond. The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women. We also aim to determine whether the potentially protective effect of multivitamin supplements on the risks of low birth weight and preterm birth translate into a sustained reduction in infant mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multivitamins | Active comparator | Dietary Supplement: Multivitamins-vitamins B-complex, C, and EMultivitamins-vitamins B-complex, C, and E |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV negative
- 12-26 weeks gestational age at screening visit
Key exclusion criteria (0 listed)
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-vitamins B-complex, C, and EOne daily oral dose of 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 mg of C, and 30 mg of vitamin E from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery. | Dietary supplement | Multivitamins |
| PlaceboOne daily oral dose of a placebo pill taken from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery. | Dietary supplement | Placebo |
Primary outcome
Fetal loss, low birth weight and pre-term birth.
Time frame: Delivery
1 secondary outcome
Child morbidity and mortality; child growth
Time frame: 12 months postpartum
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 Nov 2010.
- Results publication: PubMed 17409323Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, Willett WC, Spiegelman D. Vitamins and perinatal outcomes among HIV-negative women in Tanzania. N Engl J Med. 2007 Apr 5;356(14):1423-31. doi: 10.1056/NEJMoa064868.
- Derived from this study: PubMed 38432714Wang D, Shahab-Ferdows S, Lweno ON, Hampel D, Method B, Yelverton CA, Nguyen CH, Aboud S, Allen LH, Fawzi WW. The effects of prenatal and postnatal high-dose vitamin B-12 supplementation on human milk vitamin B-12: a randomized, double-blind, placebo-controlled trial in Tanzania. Am J Clin Nutr. 2024 Mar;119(3):730-739. doi: 10.1016/j.ajcnut.2023.07.023. Epub 2023 Nov 30.
- Derived from this study: PubMed 37181931Cliffer I, Darling AM, Madzorera I, Wang D, Perumal N, Wang M, Liu E, Pembe AB, Urassa W, Fawzi WW. Associations of Diet Quality, Socioeconomic Factors, and Nutritional Status with Gestational Weight Gain among Pregnant Women in Dar es Salaam, Tanzania. Curr Dev Nutr. 2023 Feb 4;7(3):100041. doi: 10.1016/j.cdnut.2023.100041. eCollection 2023 Mar.
- Derived from this study: PubMed 36774120Kamenju P, Madzorera I, Hertzmark E, Urassa W, Fawzi WW. Higher Dietary Intake of Animal Protein Foods in Pregnancy Is Associated with Lower Risk of Adverse Birth Outcomes. J Nutr. 2022 Nov;152(11):2546-2554. doi: 10.1093/jn/nxac183. Epub 2022 Aug 18.
- Derived from this study: PubMed 34964890Liu E, Wang D, Darling AM, Perumal N, Wang M, Urassa W, Pembe A, Fawzi WW. Multivitamin Supplementation Is Associated with Greater Adequacy of Gestational Weight Gain among Pregnant Women in Tanzania. J Nutr. 2022 Apr 1;152(4):1091-1098. doi: 10.1093/jn/nxab448.
- Derived from this study: PubMed 34151973Wang D, Natchu UCM, Darling AM, Noor RA, Hertzmark E, Urassa W, Fawzi WW. Effects of prenatal and postnatal maternal multiple micronutrient supplementation on child growth and morbidity in Tanzania: a double-blind, randomized-controlled trial. Int J Epidemiol. 2022 Dec 13;51(6):1761-1774. doi: 10.1093/ije/dyab117.
- Derived from this study: PubMed 32651998Madzorera I, Isanaka S, Wang M, Msamanga GI, Urassa W, Hertzmark E, Duggan C, Fawzi WW. Maternal dietary diversity and dietary quality scores in relation to adverse birth outcomes in Tanzanian women. Am J Clin Nutr. 2020 Sep 1;112(3):695-706. doi: 10.1093/ajcn/nqaa172.
- Derived from this study: PubMed 31605616Quinn MK, Smith ER, Williams PL, Urassa W, Shi J, Msamanga G, Fawzi WW, Sudfeld CR. The Effect of Maternal Multiple Micronutrient Supplementation on Female Early Infant Mortality Is Fully Mediated by Increased Gestation Duration and Intrauterine Growth. J Nutr. 2020 Feb 1;150(2):356-363. doi: 10.1093/jn/nxz246.
- Derived from this study: PubMed 29472265Winje BA, Kvestad I, Krishnamachari S, Manji K, Taneja S, Bellinger DC, Bhandari N, Bisht S, Darling AM, Duggan CP, Fawzi W, Hysing M, Kumar T, Kurpad AV, Sudfeld CR, Svensen E, Thomas S, Strand TA. Does early vitamin B12 supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania. BMJ Open. 2018 Feb 22;8(2):e018962. doi: 10.1136/bmjopen-2017-018962.
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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)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multivitamins-vitamins B-complex, C, and E in people with Pregnancy and Premature Birth, run by Harvard School of Public Health (HSPH).
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 2 inclusion and 0 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 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
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?
Fetal loss, low birth weight and pre-term birth. (time frame: Delivery). 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 NCT00197548, which also lists 9 linked publications.
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 Nov 2010.