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Infant MalnutritionPhase 3iLiNS-DYAD-MNCT01239693

Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)

A Phase 3 study testing IFA, MMN and LNS in people with Infant Malnutrition and Malnutrition in Pregnancy, run by Tampere University at 1 site in Malawi.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
What is being tested?
IFA, MMN and LNS
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,391 participants
Where
1 siteMalawi
Study dates
Feb 2011to 31 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Ultrasound confirmed pregnancy of no more than 20 completed gestation weeks
  • Permanent resident of Mangochi District Hospital, Malindi Hospital or Lungwena Health Centre catchment areas
  • Availability during the period of the study
  • Signed informed consent

Who cannot join

  • Less than 15 years of age
  • Need for frequent medical attention due to a chronic health condition
  • Diagnosed asthma treated with regular medication
  • Severe illness warranting hospital referral
  • History of allergy towards peanuts
  • History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
Show all 9Show fewer
  • Pregnancy complications evident at enrolment visit (moderate to severe oedema, blood Hb concentration < 5 g / dl, systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg)
  • Earlier participation in the iLiNS-DYAD-M trial
  • Concurrent participation in any other clinical trial

Trial locations and contacts

1 site in 1 country.

Malawi1 site

  • University of Malawi, College of Medicine

    Mangochi

Other trials in Malawi

About this study

Official title: A Research Plan for a Randomised, Single-blind, Parallel Group Controlled Trial in Rural Malawi, Testing the Health Effects of Supplementing Maternal Diet During Pregnancy and Lactation and Infant Diet From 6 to 18 Months of Age With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)

The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating women and their infants from 6 to 18 months of age. In control groups, participants will receive either iron+folate tables during pregnancy only or multiple micronutrient tablets during pregnancy and first six months of lactations. The main hypothesis to be tested suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and the first 6 months of lactation is higher than the mean LAZ score of same age infants who received no dietary supplements and whose mothers received iron-folate supplementation during pregnancy only.

To detect the long-term effect of the LNS supplementation, we now propose to conduct a follow-up study when the children are 9 years old, to see if the intervention had effect on children's growth, cardiometabolic and respiratory status and neurocognitive development.

Read the detailed description

Pregnant women will be identified from the antenatal clinics of 4 governmental and 2 other health centres. A total of 1400 women meeting set criteria will be randomised into receiving one of the following interventions: 1) Iron and folic acid supplementation to the mother during pregnancy only (IFA group), 2). Multiple micronutrient supplementation to the mother during pregnancy and six months thereafter (MMN group), 3) Lipid-based nutrient supplements to the mother during pregnancy and six months thereafter and to the child from 6 to 18 months of age (LNS group).

The mothers will receive LNS or the multiple micronutrients at 2-weekly intervals at their homes during pregnancy and weekly during first six months of lactation. Children in the LNS group will receive LNS weekly, starting at 6 months. Mothers will be medically examined and tested for defined laboratory parameters at enrolment, at 36 gestation weeks, at birth or soon thereafter, and at 6 months after delivery. Child size will be assessed at birth or soon thereafter and at 3, 6, 12, and 18 months of age. The mothers will undergo a morbidity evaluation fortnightly and the children weekly.

864 mother-infant pairs will undergo the complete intervention and follow-up, as described above. The remaining 536 participants will undergo a simplified intervention and follow-up, in which there are no interventions after birth and the child follow-up consists only of 4 3 health centre and one home visits; first at 1 week, then at six weeks (at home) and at 6 and 18 months of age.

A sub-study on the the development of intestinal microbiome was added in August 2011. This entails the collection of stool samples from the mother at 1 month after delivery, breast milk samples from the mothers at 1, 3, and 6 months after delivery and stool and urine samples from the children repeated during the a8 months of intervention. The aim of this subproject is to study the development of the infants' intestinal microbiota, its predictors and its association to child growth and other health outcomes. At the same time point, the sample size was reduced from 2400 to 1400 participants (due to constraints in funding).

A one year post-intervention follow-up for participants in the complete follow-up was added to the study protocol in August 2013. The intervention will be stopped when the participants are 18 months old. Thereafter, there will be an anthropometrirc assessment and blood and urine draw at the study clinic at 24 and 30 months of age. Stool samples will be collected from the participants at the age of 21, 24, 27 and 30 months, to study the development of intestinal microbiome.

In a follow-up study, when the children are 10 years old, we will assess:

  1. child growth using standard anthropometric measures,
  2. cardiometabolic health by measuring body composition, blood pressure and plasma lipids,
  3. neurodevelopment by measuring neural function, cognitive skills and education attainment using EE and EGMA and Raven's questionnaires,
  4. lung function with spirometry and allergy symptoms and asthma using ISAAC questionnaire.
Being tested
IFA, MMN, LNS
Keywords
Stunting, Growth failure, Malnutrition, Lipid based nutrient supplement, LNS, Prevention, Malawi, Sub-Saharan Africa, Dietary supplementation, Efficacy, Pregnancy, Infancy, Newborn, Child neurocognitive development, Cardiometabolic health, Lung function
Medical subject headings
Infant Nutrition Disorders, Growth Disorders, Failure to Thrive, Malnutrition

What participants receive

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

  • IFADietary supplement

    Women during pregnancy: 1 tablet of iron+ folate daily until delivery (60 mg iron + 400 ug folic acid) Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of calcium (200 mg), akin to placebo Children from 6 to 18 months of age: None

  • MMNDietary supplement

    Women during pregnancy: 1 tablet of multiple micronutrients daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of multiple micronutrients Children from 6 to 18 months of age: None

  • LNSDietary supplement

    Women during pregnancy: 1 sachet of LNS-P\&L (20 g of LNS) daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily sachet of LNS-P\&L (20 g of LNS) Children from 6 to 18 months of age: 2 daily sachet of LNS-20gM (20 g of LNS)

Study groups in NCT01239693
Study groupRoleWhat they receive
IFA groupActive comparatorWomen during pregnancy: 1 tablet of iron+ folate daily until delivery (60 mg iron + 400 ug folic acid) Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of calcium (200 mg), akin to placebo Children from 6 to 18 months of age: None
Receives: Dietary Supplement: IFA
MMN groupActive comparatorWomen during pregnancy: 1 tablet of multiple micronutrients daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of multiple micronutrients' Children from 6 to 18 months of age: None
Receives: Dietary Supplement: MMN
LNS groupExperimentalWomen during pregnancy: 1 sachet of LNS-P\&L (20 g of LNS) daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily sachet of LNS-P\&L (20 g of LNS) Children from 6 to 18 months of age: 2 daily sachet of LNS-20gM (20 g of LNS)
Receives: Dietary Supplement: LNS

What is being measured

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

  1. Birth weight

    Measured: approx 20 weeks after enrollment (within 48 hours)

  2. Newborn length

    Measured: At 1 week of age

  3. Length for age Z-score (LAZ) at 18 months of age

    Measured: 12 months after enrollment (age 18 months)

Secondary outcomes (61)

  1. Anthropometric status (weight, BMI, mid upper arm circumference and triceps and sub-scapular skin-fold thickness)

    Measured: at ~ 36 wk gestation and 6 months postpartum

  2. Gestational age at delivery, proportion of preterm deliveries

    Measured: At delivery

  3. Proportion of low birth weight babies

    Measured: At birth

  4. Anaemia and iron status (Hb, ZPP, transferrin receptor), other micronutrient status (vitamin A, B-vitamins, zinc), malarial antigen

    Measured: At ~ 36 wk gestation and 6 mo postpartum

  5. Red blood cell essential fatty acid status

    Measured: At ~ 36 wk gestation

  6. Urinary iodine

    Measured: At ~ 36 wk gestation

  7. Total plasma cholesterol concentration

    Measured: At ~ 36 wk gestation

  8. Basal salivary cortisol concentration

    Measured: At ~ 28 and ~ 36 wk gestation

  9. Blood pressure

    Measured: At 36 wk gestation

  10. Breast milk composition (essential fatty acids, vitamin A, B-vitamins)

    Measured: At 6 mo postpartum

  11. Depressive symptoms (which may be related to essential fatty acid status)

    Measured: At 4 weeks and at 6 months postpartum

  12. Incidence of febrile malaria episodes

    Measured: During pregnancy

  13. Peripheral blood malaria parasitaemia

    Measured: At 32 wk gestation and at delivery

  14. Placental malaria histology

    Measured: At delivery

  15. Evidence of defined bacteria in the chorionic membranes at delivery (quantitative DNA amplification method)

    Measured: At birth

  16. Prevalence of Neisseria gonorrhoea, Chlamydia trachomatis, in swab samples taken from maternal uterine cervix(qualitative DNA amplification method)

    Measured: At one week after delivery

  17. Prevalence of bacterial vaginosis, Trichomonas vaginalis, or candidiasis, in swab samples taken from maternal vagina(direct microscopy)

    Measured: At one week after delivery

  18. Malaria immunity

    Measured: At enrolment, at ~ 36 wk gestation, and 6 months post-partum

  19. Anthropometric infant status (weight, length, head circumference and mid upper arm circumference)

    Measured: At 7 days of age and at 6, 12 and 18 months of age. After the intervention at 24 and 30 months and at 10 y of age.

  20. Infant anaemia and iron status (Hb, ZPP), micronutrient (vitamin A, B-vitamins) and essential fatty acids status, evidence of acute inflammation (CRP, AGP), and malarial antigen and microscopy

    Measured: At 6 and 18 months of age

  21. Incidence of neonatal hospitalizations

    Measured: At or before age 28 days

  22. Clinical morbidity

    Measured: Between 0 and 18 months of age

  23. Child feeding practices and maternal report of child sleep patterns

    Measured: At 6, 12 and 18 months of age

  24. Antibody response to measles vaccination

    Measured: At 18 months of age

  25. Malaria immunity

    Measured: At 6 and 18 months of age

  26. Basal salivary cortisol concentration

    Measured: At 6, 12 and 18 months of age

  27. Cortisol response to acute stress

    Measured: At 6 and 18 months of age

  28. Achievement of five motor milestones and four other developmental milestones

    Measured: From 0 to 18 mo

  29. Neurobehavioral development

    Measured: At 18 months of age

  30. Incidence of serious adverse events

    Measured: During pregnancy and 18 months of infant follow-up

  31. Prevalence of maternal periodontitis

    Measured: At one week after delivery

  32. Maternal cognition

    Measured with several different tests

    Measured: 6 months after delivery

  33. Mother - child interaction

    Measured with a number of observational tests and questionnaires

    Measured: 6 months after delivery

  34. The composition of intestinal microbiota

    Done with 16s sequencing, from stored stool samples

    Measured: 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months of child age

  35. diastolic blood pressure

    Mobil-o-Graph blood pressure monitoring system

    Measured: Child is 10 years

  36. central blood pressure

    Mobil-o-Graph blood pressure monitoring system

    Measured: Child is 10 years

  37. pulse rate

    Mobil-o-Graph blood pressure monitoring system

    Measured: Child is 10 years

  38. vascular resistance

    Mobil-o-Graph blood pressure monitoring system

    Measured: Child is 10 years

  39. plasma concentration of glucose

    Cobas c702 machine

    Measured: Child is 10 years

  40. plasma concentration of cholesterol

    Cobas c702 machine

    Measured: Child is 10 years

  41. plasma concentration of HDL/LDL cholesterol

    Cobas c702 machine

    Measured: Child is 10 years

  42. plasma concentration of triglycerides

    Cobas c702 machine

    Measured: Child is 10 years

  43. plasma concentration of c-reactive protein

    Cobas c702 machine

    Measured: Child is 10 years

  44. plasma concentration of alkaline phosphatase

    Cobas c702 machine

    Measured: Child is 10 years

  45. plasma concentration of aspartyl alanine transferase

    Cobas c702 machine

    Measured: Child is 10 years

  46. plasma concentration of potassium

    Cobas c702 machine

    Measured: Child is 10 years

  47. plasma concentration of sodium

    Cobas c702 machine

    Measured: Child is 10 years

  48. plasma concentration of urate

    Cobas c702 machine

    Measured: Child is 10 years

  49. Spirometry measures functional volume of the lungs

    Global Lung Function Initiative standards, Medikro pro spirometry

    Measured: Child is 10 years

  50. asthma symptoms

    ISAAC questionnaire

    Measured: Child is 10 years

  51. allergy symptoms

    ISAAC questionnaire

    Measured: Child is 10 years

  52. neural functioning

    EEG

    Measured: Child is 10 years

  53. processing speed

    EEG

    Measured: Child is 10 years

  54. oculomotor reaction time

    eye-tracking

    Measured: Child is 10 years

  55. academic achievement

    Early Grade Mathematics Assessment, EGMA

    Measured: Child is 10 years

  56. height

    Measured: Child is 10 years

  57. sitting height

    Measured: Child is 10 years

  58. weight

    Measured: Child is 10 years

  59. head circumference

    Measured: Child is 10 years

  60. mid-upper arm circumference

    Measured: Child is 10 years

  61. body composition

    Tanita MC-780 MAS

    Measured: Child is 10 years

Timeline

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

  1. First posted11 Nov 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionApr 2015
  4. Study completion31 Mar 2027 (estimated)

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
Single blind
Who is masked
Outcomes assessor
Enrolment
1,391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01239693
Sponsor's protocol ID
iLiNS-DYAD-M
Acronym
iLiNS-DYAD-M
Status last verified
Mar 2025
First submitted
10 Nov 2010
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Adu-Afarwuah S, Arnold CD, Lartey A, Okronipa H, Maleta K, Ashorn P, Ashorn U, Dewey KG. Prevalence of morbidity symptoms among pregnant and postpartum women receiving different nutrient supplements in Ghana and Malawi: A secondary outcome analysis of two randomised controlled trials. Matern Child Nutr. 2023 Jul;19(3):e13501. doi: 10.1111/mcn.13501. Epub 2023 Apr 6.

    PubMed 37021807

  • Liu Z, Fan YM, Ashorn P, Chingwanda C, Maleta K, Hallamaa L, Hyoty H, Chaima D, Ashorn U. Lack of Associations between Environmental Exposures and Environmental Enteric Dysfunction among 18-Month-Old Children in Rural Malawi. Int J Environ Res Public Health. 2022 Sep 1;19(17):10891. doi: 10.3390/ijerph191710891.

    PubMed 36078607

  • Salenius M, Pyykko J, Ashorn U, Dewey KG, Gondwe A, Harjunmaa U, Maleta K, Nkhoma M, Vosti SA, Ashorn P, Adubra L. Association between prenatal provision of lipid-based nutrient supplements and caesarean delivery: Findings from a randomised controlled trial in Malawi. Matern Child Nutr. 2022 Oct;18(4):e13414. doi: 10.1111/mcn.13414. Epub 2022 Jul 31.

    PubMed 35909334

  • Haskell MJ, Maleta K, Arnold CD, Jorgensen JM, Fan YM, Ashorn U, Matchado A, Monangi NK, Zhang G, Xu H, Belling E, Landero J, Chappell J, Muglia LJ, Hallman M, Ashorn P, Dewey KG. Provision of Small-Quantity Lipid-Based Nutrient Supplements Increases Plasma Selenium Concentration in Pregnant Women in Malawi: A Secondary Outcome of a Randomized Controlled Trial. Curr Dev Nutr. 2022 Mar 7;6(3):nzac013. doi: 10.1093/cdn/nzac013. eCollection 2022 Mar.

    PubMed 35317414

  • Smith JW, Matchado AJ, Wu LS, Arnold CD, Burke SM, Maleta KM, Ashorn P, Stewart CP, Shaikh S, Ali H, Labrique AB, West KP Jr, Christian P, Dewey KG, Groopman JD, Schulze KJ. Longitudinal Assessment of Prenatal, Perinatal, and Early-Life Aflatoxin B1 Exposure in 828 Mother-Child Dyads from Bangladesh and Malawi. Curr Dev Nutr. 2022 Jan 7;6(2):nzab153. doi: 10.1093/cdn/nzab153. eCollection 2022 Feb.

    PubMed 35155983

  • Kortekangas E, Fan YM, Chaima D, Lehto KM, Malamba-Banda C, Matchado A, Chingwanda C, Liu Z, Ashorn U, Cheung YB, Dewey KG, Maleta K, Ashorn P. Associations between Gut Microbiota and Intestinal Inflammation, Permeability and Damage in Young Malawian Children. J Trop Pediatr. 2022 Feb 3;68(2):fmac012. doi: 10.1093/tropej/fmac012.

    PubMed 35149871

  • Adu-Afarwuah S, Arnold CD, Lartey A, Okronipa H, Maleta K, Ashorn P, Ashorn U, Fan YM, Matchado A, Kortekangas E, Oaks BM, Jackson KH, Dewey KG. Small-Quantity Lipid-Based Nutrient Supplements Increase Infants' Plasma Essential Fatty Acid Levels in Ghana and Malawi: A Secondary Outcome Analysis of the iLiNS-DYAD Randomized Trials. J Nutr. 2022 Jan 11;152(1):286-301. doi: 10.1093/jn/nxab329.

    PubMed 34543432

  • Jorgensen JM, Young R, Ashorn P, Ashorn U, Chaima D, Davis JCC, Goonatilleke E, Kumwenda C, Lebrilla CB, Maleta K, Sadalaki J, Totten SM, Wu LD, Zivkovic AM, Dewey KG. Associations of Human Milk Oligosaccharides and Bioactive Proteins with Infant Morbidity and Inflammation in Malawian Mother-Infant Dyads. Curr Dev Nutr. 2021 Apr 29;5(5):nzab072. doi: 10.1093/cdn/nzab072. eCollection 2021 May.

    PubMed 34084993

  • Jorgensen JM, Young R, Ashorn P, Ashorn U, Chaima D, Davis JCC, Goonatilleke E, Kumwenda C, Lebrilla CB, Maleta K, Prado EL, Sadalaki J, Totten SM, Wu LD, Zivkovic AM, Dewey KG. Associations of human milk oligosaccharides and bioactive proteins with infant growth and development among Malawian mother-infant dyads. Am J Clin Nutr. 2021 Jan 4;113(1):209-220. doi: 10.1093/ajcn/nqaa272.

    PubMed 33096556

  • Adu-Afarwuah S, Arnold CD, Maleta K, Ashorn P, Ashorn U, Jorgensen JM, Fan YM, Nkhoma M, Bendabenda J, Matchado A, Dewey KG. Consumption of multiple micronutrients or small-quantity lipid-based nutrient supplements containing iodine at the recommended dose during pregnancy, compared with iron and folic acid, does not affect women's urinary iodine concentration in rural Malawi: a secondary outcome analysis of the iLiNS DYAD trial. Public Health Nutr. 2021 Jul;24(10):3049-3057. doi: 10.1017/S1368980020003250. Epub 2020 Oct 15.

    PubMed 33054890

  • Kamng'ona AW, Young R, Arnold CD, Patson N, Jorgensen JM, Kortekangas E, Chaima D, Malamba C, Ashorn U, Cheung YB, Ashorn P, Maleta K, Dewey KG. Provision of Lipid-Based Nutrient Supplements to Mothers During Pregnancy and 6 Months Postpartum and to Their Infants from 6 to 18 Months Promotes Infant Gut Microbiota Diversity at 18 Months of Age but Not Microbiota Maturation in a Rural Malawian Setting: Secondary Outcomes of a Randomized Trial. J Nutr. 2020 Apr 1;150(4):918-928. doi: 10.1093/jn/nxz298.

    PubMed 31909811

  • Kortekangas E, Young R, Cheung YB, Fan YM, Jorgensen JM, Kamng'ona AW, Chaima D, Ashorn U, Dewey KG, Maleta K, Ashorn P. A Prospective Study on Child Morbidity and Gut Microbiota in Rural Malawi. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):431-437. doi: 10.1097/MPG.0000000000002435.

    PubMed 31436705

  • Bendabenda J, Patson N, Hallamaa L, Ashorn U, Dewey KG, Ashorn P, Maleta K. Does anthropometric status at 6 months predict the over-dispersion of malaria infections in children aged 6-18 months? A prospective cohort study. Malar J. 2019 Apr 22;18(1):143. doi: 10.1186/s12936-019-2778-y.

    PubMed 31010435

  • Barua P, Beeson JG, Maleta K, Ashorn P, Rogerson SJ. The impact of early life exposure to Plasmodium falciparum on the development of naturally acquired immunity to malaria in young Malawian children. Malar J. 2019 Jan 18;18(1):11. doi: 10.1186/s12936-019-2647-8.

    PubMed 30658632

  • Oaks BM, Jorgensen JM, Baldiviez LM, Adu-Afarwuah S, Maleta K, Okronipa H, Sadalaki J, Lartey A, Ashorn P, Ashorn U, Vosti S, Allen LH, Dewey KG. Prenatal Iron Deficiency and Replete Iron Status Are Associated with Adverse Birth Outcomes, but Associations Differ in Ghana and Malawi. J Nutr. 2019 Mar 1;149(3):513-521. doi: 10.1093/jn/nxy278.

    PubMed 30629202

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IFA, MMN and LNS in people with Infant Malnutrition and Malnutrition in Pregnancy, run by Tampere University at 1 site in Malawi.

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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. 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 Malawi. 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?

This study is still under way. Results are not available in the source record yet.

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 (time frame: approx 20 weeks after enrollment (within 48 hours)). The study lists 3 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 NCT01239693, which also lists 30 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 28 Mar 2025.

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