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Perinatal MortalityPhase 3NCT00133744

Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

A Phase 3 study testing folic acid, folic acid plus iron and supplements with multiple vitamins and minerals in people with Perinatal Mortality and Stillbirth, run by Centers for Disease Control and Prevention at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through delivery reduces perinatal mortality compared with a daily prenatal supplement of folic acid… Read more about this study

Who is it for?
Ages 20 years and older, women onlyHealthy volunteers can take part
What is being tested?
folic acid, folic acid plus iron and supplements with multiple vitamins and minerals
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18,962 participants
Where
5 sitesChina
Study dates
May 2006to Dec 2010
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 20 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Live in one of the study counties (Laoting, Mancheng, Fengrun, Xianghe, Yuanshi)
  • Can follow instructions
  • Can swallow pills

Who cannot join

  • >= 20 weeks gestation at enrollment
  • Previous live birth
  • Anemic (hemoglobin [Hb] <10 g/dl in 1st trimester and < 9.5 g/dl in 2nd trimester) at enrollment
  • Current use of iron or other vitamin or mineral supplements (except folic acid)
  • Age < 20 years at enrollment
  • Under treatment for anemia at enrollment
  • Refuse to participate

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Fengrun Maternal and Child Health Institute

    Fengrun, Hebei, 064000

  • Yuanshi Maternal and Child Health Institute

    Huaiyang, Hebei, 051130

  • Laoting Maternal and Child Health Institute

    Laoting, Hebei, 063600

  • Mancheng Maternal and Child Health Institute

    Mancheng, Hebei, 072150

  • Xianghe Maternal and Child Health Institute

    Xianghe, Hebei, 065400

Other trials in China

About this study

Official title: Impact of Iron/Folic Acid Versus Multimicronutrient Versus Folic Acid Supplements During Pregnancy on Mortality, Morbidity, and Complications During Pregnancy, Labor, and Delivery: A Randomized Controlled Trial in China

The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through delivery reduces perinatal mortality compared with a daily prenatal supplement of folic acid alone.

Read the detailed description

In the project area in China, the rate of perinatal mortality (stillbirths and infant deaths within 6 days of birth) is two times that of the United States. Causes of perinatal mortality include, but are not limited to, low birth weight and preterm delivery. Anemia (low hemoglobin) among pregnant women is associated with low birth weight and preterm delivery and also is elevated in the project area. Supplements of iron, folic acid, and other vitamins and minerals can prevent anemia among pregnant women, but the effects of these supplements on other maternal and infant health outcomes are unclear.

Since 1993, the People's Republic of China has recommended that newly married women, and those who plan pregnancy, take 400μg of folic acid daily through the first trimester of pregnancy. Although WHO recommends that pregnant women take iron and folic acid supplements, there is currently no national recommendation that pregnant women in China take iron or other vitamin or mineral supplements (other than folic acid). UNICEF is now testing a prenatal vitamin and mineral supplement in programs to prevent low birth weight. Our study will provide additional information about the health impact of the UNICEF prenatal supplement versus an iron and folic acid supplement versus folic acid alone.

Comparisons:

  • Infants of women who receive daily prenatal supplements that contain 400μg folic acid alone, will be compared with infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid.
  • Infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid will be compared with infants of women who receive a daily supplement containing 30 mg iron, 400μg folic acid and other vitamins and minerals (UNICEF formulation).
Being tested
folic acid, folic acid plus iron, supplements with multiple vitamins and minerals
Keywords
pregnancy, vitamins, minerals, supplements, mortality, prenatal, perinatal, anemia, birthweight, preterm, iron, micronutrients, Stillbirths, Early neonatal deaths
Medical subject headings
Perinatal Death, Stillbirth, Anemia, Birth Weight, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • folic acidDietary supplement

    pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid

  • folic acid plus ironDietary supplement

    pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe

  • supplements with multiple vitamins and mineralsDietary supplement

    Also called UNIMMAP

    pills, one per day, from the first prenatal visit until delivery; folic acid 400 mcg, Fe 30 mg, vitamin(vit) A 800 mcg, vit E 10 mg, vit D 5 mcg, vit C 70 mg, vit B1 1.4 mg, vit B2 1.4 mg, vit B6 1.9 mg, vit B12 2.6 mcg, Niacin 18 mg, Zn 15 mg, Cu 2mg, Iodine 150 mcg, Selenium 65 mcg

Study groups in NCT00133744
Study groupRoleWhat they receive
A, 1Active comparatorNot described
Receives: Dietary Supplement: folic acid
A, 2ExperimentalNot described
Receives: Dietary Supplement: folic acid plus iron
A, 3ExperimentalMultiple micronutrient supplement
Receives: Dietary Supplement: supplements with multiple vitamins and minerals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perinatal mortality, i.e., the number of stillbirths (fetal deaths of 28 weeks or more of gestation) and the number of deaths within the first 0-6 days of life per 1000 births (live births and stillbirths)

    Measured: 20 weeks gestation to 6 days postpartum

Secondary outcomes (7)

  1. Maternal anemia

    Measured: 24-28 weeks gestation

  2. Maternal anemia

    Measured: 4-8 weeks postpartum

  3. Infant gestational age at birth, preterm delivery

    Measured: delivery

  4. Infant birth weight, low birth weight

    Measured: at birth

  5. Infant low weight-for-height

    Measured: infant age 6 months and 12 months

  6. Infant anemia

    Measured: 6 months and 12 months of age

  7. maternal gastrointestinal side effects

    Measured: monthly from a month after enrollment until delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2005 (estimated)
  2. Study startMay 2006
  3. Primary completionDec 2009
  4. Study completionDec 2010

Resources

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
18,962 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00133744
Sponsor's protocol ID
CDC-NCCDPHP-4084
Status last verified
Mar 2011
First submitted
22 Aug 2005
Last updated
21 Mar 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Si KY, Li HT, Zhou YB, Li ZW, Zhang L, Zhang YL, Ye RW, Liu JM. Cesarean delivery on maternal request and common child health outcomes: A prospective cohort study in China. J Glob Health. 2022 Feb 26;12:11001. doi: 10.7189/jogh.12.11001. eCollection 2022.

    PubMed 35265334

  • Liu Y, Li N, Mei Z, Li Z, Ye R, Zhang L, Li H, Zhang Y, Liu JM, Serdula MK. Effects of prenatal micronutrients supplementation timing on pregnancy-induced hypertension: Secondary analysis of a double-blind randomized controlled trial. Matern Child Nutr. 2021 Jul;17(3):e13157. doi: 10.1111/mcn.13157. Epub 2021 Feb 16.

    PubMed 33594802

  • Chen S, Li N, Mei Z, Ye R, Li Z, Liu J, Serdula MK. Micronutrient supplementation during pregnancy and the risk of pregnancy-induced hypertension: A randomized clinical trial. Clin Nutr. 2019 Feb;38(1):146-151. doi: 10.1016/j.clnu.2018.01.029. Epub 2018 Feb 15.

    PubMed 29428785

  • Zhang Y, Jin L, Liu JM, Ye R, Ren A. Maternal Hemoglobin Concentration during Gestation and Risk of Anemia in Infancy: Secondary Analysis of a Randomized Controlled Trial. J Pediatr. 2016 Aug;175:106-110.e2. doi: 10.1016/j.jpeds.2016.05.011. Epub 2016 Jun 2.

    PubMed 27263403

  • Liu JM, Mei Z, Ye R, Serdula MK, Ren A, Cogswell ME. Micronutrient supplementation and pregnancy outcomes: double-blind randomized controlled trial in China. JAMA Intern Med. 2013 Feb 25;173(4):276-82. doi: 10.1001/jamainternmed.2013.1632.

    PubMed 23303315

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing folic acid, folic acid plus iron and supplements with multiple vitamins and minerals in people with Perinatal Mortality and Stillbirth, run by Centers for Disease Control and Prevention at 5 sites in China.

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 3 inclusion and 7 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 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. 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 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?

Perinatal mortality, i.e., the number of stillbirths (fetal deaths of 28 weeks or more of gestation) and the number of deaths within the first 0-6 days of life per 1000 births (live births and stillbirths) (time frame: 20 weeks gestation to 6 days postpartum). 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 NCT00133744, which also lists 5 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 21 Mar 2011.

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