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AzTrials

Low Birth WeightPhase 3NCT00115271

Antenatal Micronutrient Supplementation and Birth Weight

A Phase 3 study testing Nutritional supplements in people with Low Birth Weight and Infant Mortality, run by Johns Hopkins Bloomberg School of Public Health.

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 was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of Nepal. Read more about this study

Who is it for?
Ages 15 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Low Birth Weight, Infant Mortality, Pregnancy
What is being tested?
Nutritional supplements
How many people
5,000 participants
Where
No sites listed yet
Study dates
Jan 1999to May 2001
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 15 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Married women of reproductive age identified as a new pregnancy using a urine test

Who cannot join

  • Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant <9 months of age

About this study

Official title: Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal

The purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of Nepal.

Read the detailed description

Maternal micronutrient deficiencies are common in the developing world and may influence intrauterine growth and fetal and neonatal health and survival. Currently, policies for antenatal supplementation beyond iron-folic acid are not in place in these settings. And yet, the efficacy of such supplementation strategies has not been well established. Specifically, it is not clear if multiple micronutrient combinations will enhance fetal growth and newborn health and survival compared to single or smaller combinations of micronutrients. Also, while birth weight may serve as a proxy measure of newborn health, infant morbidity and mortality needs direct examination.

Comparisons: Pregnant women received daily folic acid, folic acid plus iron, folic acid plus iron plus zinc, or a multiple micronutrient supplement containing 11 other nutrients all with vitamin A compared to a control group that received only vitamin A.

Being tested
Nutritional supplements
Keywords
Micronutrients, Supplementation, Pregnancy, Birth weight, Infant mortality
Medical subject headings
Infant Death, Birth Weight

What participants receive

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

  • Nutritional supplementsDrug

What is being measured

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

  1. Birth weight

  2. 3-month infant mortality

Secondary outcomes (5)

  1. Infant morbidity

  2. Maternal morbidity

  3. Maternal nutritional status

  4. Weight gain during pregnancy

  5. Infant growth

Timeline

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

  1. First posted22 Jun 2005 (estimated)
  2. Study startJan 1999
  3. Primary completionMay 2001
  4. Study completionMay 2001

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
Double blind
Enrolment
5,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00115271
Sponsor's protocol ID
H.22.98.09.02.C1
Status last verified
Aug 2014
First submitted
21 Jun 2005
Last updated
26 Aug 2014
Results posted
No

Publications

  • Subedi S, Katz J, Erchick DJ, Verhulst A, Khatry SK, Mullany LC, Tielsch JM, LeClerq SC, Christian P, West KP, Guillot M. Does higher early neonatal mortality in boys reverse over the neonatal period? A pooled analysis from three trials of Nepal. BMJ Open. 2022 May 19;12(5):e056112. doi: 10.1136/bmjopen-2021-056112.

    PubMed 35589346

  • Eroglu A, Schulze KJ, Yager J, Cole RN, Christian P, Nonyane BAS, Lee SE, Wu LSF, Khatry S, Groopman J, West KP Jr. Plasma proteins associated with circulating carotenoids in Nepalese school-aged children. Arch Biochem Biophys. 2018 May 15;646:153-160. doi: 10.1016/j.abb.2018.03.025. Epub 2018 Mar 30.

    PubMed 29605494

  • Lee SE, Stewart CP, Schulze KJ, Cole RN, Wu LS, Yager JD, Groopman JD, Khatry SK, Adhikari RK, Christian P, West KP Jr. The Plasma Proteome Is Associated with Anthropometric Status of Undernourished Nepalese School-Aged Children. J Nutr. 2017 Mar;147(3):304-313. doi: 10.3945/jn.116.243014. Epub 2017 Feb 1.

    PubMed 28148680

  • West KP Jr, Cole RN, Shrestha S, Schulze KJ, Lee SE, Betz J, Nonyane BA, Wu LS, Yager JD, Groopman JD, Christian P. A Plasma alpha-Tocopherome Can Be Identified from Proteins Associated with Vitamin E Status in School-Aged Children of Nepal. J Nutr. 2015 Dec;145(12):2646-56. doi: 10.3945/jn.115.210682. Epub 2015 Oct 7.

    PubMed 26446483

  • Cole RN, Ruczinski I, Schulze K, Christian P, Herbrich S, Wu L, Devine LR, O'Meally RN, Shrestha S, Boronina TN, Yager JD, Groopman J, West KP Jr. The plasma proteome identifies expected and novel proteins correlated with micronutrient status in undernourished Nepalese children. J Nutr. 2013 Oct;143(10):1540-8. doi: 10.3945/jn.113.175018. Epub 2013 Aug 21.

    PubMed 23966331

  • Christian P, Morgan ME, Murray-Kolb L, LeClerq SC, Khatry SK, Schaefer B, Cole PM, Katz J, Tielsch JM. Preschool iron-folic acid and zinc supplementation in children exposed to iron-folic acid in utero confers no added cognitive benefit in early school-age. J Nutr. 2011 Nov;141(11):2042-8. doi: 10.3945/jn.111.146480. Epub 2011 Sep 28.

    PubMed 21956955

  • Christian P, Murray-Kolb LE, Khatry SK, Katz J, Schaefer BA, Cole PM, Leclerq SC, Tielsch JM. Prenatal micronutrient supplementation and intellectual and motor function in early school-aged children in Nepal. JAMA. 2010 Dec 22;304(24):2716-23. doi: 10.1001/jama.2010.1861.

    PubMed 21177506

  • Lee AC, Darmstadt GL, Khatry SK, LeClerq SC, Shrestha SR, Christian P. Maternal-fetal disproportion and birth asphyxia in rural Sarlahi, Nepal. Arch Pediatr Adolesc Med. 2009 Jul;163(7):616-23. doi: 10.1001/archpediatrics.2009.75.

    PubMed 19581544

  • Christian P, Darmstadt GL, Wu L, Khatry SK, Leclerq SC, Katz J, West KP Jr, Adhikari RK. The effect of maternal micronutrient supplementation on early neonatal morbidity in rural Nepal: a randomised, controlled, community trial. Arch Dis Child. 2008 Aug;93(8):660-4. doi: 10.1136/adc.2006.114009.

    PubMed 18644934

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nutritional supplements in people with Low Birth Weight and Infant Mortality, run by Johns Hopkins Bloomberg School of Public Health.

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 1 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 26 Aug 2014. 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. 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?

Birth weight. The study lists 2 primary outcomes in all. 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 NCT00115271, 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 26 Aug 2014.

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