Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS) (iLiNS-DYAD-M)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant Malnutrition Malnutrition in Pregnancy |
Dietary Supplement: IFA Dietary Supplement: MMN Dietary Supplement: LNS |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| 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) |
- Birth weight [ Time Frame: approx 20 weeks after enrollment (within 48 hours) ] [ Designated as safety issue: No ]
- Newborn length [ Time Frame: At 1 week of age ] [ Designated as safety issue: No ]
- Length for age Z-score (LAZ) at 18 months of age [ Time Frame: 12 months after enrollment (age 18 months) ] [ Designated as safety issue: No ]
- Anthropometric status (weight, BMI, mid upper arm circumference and triceps and sub-scapular skin-fold thickness) [ Time Frame: at ~ 36 wk gestation and 6 months postpartum ] [ Designated as safety issue: No ]
- Gestational age at delivery, proportion of preterm deliveries [ Time Frame: At delivery ] [ Designated as safety issue: No ]
- Proportion of low birth weight babies [ Time Frame: At birth ] [ Designated as safety issue: No ]
- Anaemia and iron status (Hb, ZPP, transferrin receptor), other micronutrient status (vitamin A, B-vitamins, zinc), malarial antigen [ Time Frame: At ~ 36 wk gestation and 6 mo postpartum ] [ Designated as safety issue: No ]
- Red blood cell essential fatty acid status [ Time Frame: At ~ 36 wk gestation ] [ Designated as safety issue: No ]
- Urinary iodine [ Time Frame: At ~ 36 wk gestation ] [ Designated as safety issue: No ]
- Total plasma cholesterol concentration [ Time Frame: At ~ 36 wk gestation ] [ Designated as safety issue: No ]
- Basal salivary cortisol concentration [ Time Frame: At ~ 28 and ~ 36 wk gestation ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: At 36 wk gestation ] [ Designated as safety issue: No ]
- Breast milk composition (essential fatty acids, vitamin A, B-vitamins) [ Time Frame: At 6 mo postpartum ] [ Designated as safety issue: No ]
- Depressive symptoms (which may be related to essential fatty acid status) [ Time Frame: At 4 weeks and at 6 months postpartum ] [ Designated as safety issue: No ]
- Incidence of febrile malaria episodes [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
- Peripheral blood malaria parasitaemia [ Time Frame: At 32 wk gestation and at delivery ] [ Designated as safety issue: No ]
- Placental malaria histology [ Time Frame: At delivery ] [ Designated as safety issue: No ]
- Evidence of defined bacteria in the chorionic membranes at delivery (quantitative DNA amplification method) [ Time Frame: At birth ] [ Designated as safety issue: No ]
- Prevalence of Neisseria gonorrhoea, Chlamydia trachomatis, in swab samples taken from maternal uterine cervix(qualitative DNA amplification method) [ Time Frame: At one week after delivery ] [ Designated as safety issue: No ]
- Prevalence of bacterial vaginosis, Trichomonas vaginalis, or candidiasis, in swab samples taken from maternal vagina(direct microscopy) [ Time Frame: At one week after delivery ] [ Designated as safety issue: No ]
- Malaria immunity [ Time Frame: At enrolment, at ~ 36 wk gestation, and 6 months post-partum ] [ Designated as safety issue: No ]
- Anthropometric infant status (weight, length, head circumference and mid upper arm circumference) [ Time Frame: At 7 days of age and at 6, 12 and 18 months of age ] [ Designated as safety issue: No ]
- 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 [ Time Frame: At 6 and 18 months of age ] [ Designated as safety issue: No ]
- Incidence of neonatal hospitalizations [ Time Frame: At or before age 28 days ] [ Designated as safety issue: No ]
- Clinical morbidity [ Time Frame: Between 0 and 18 months of age ] [ Designated as safety issue: No ]
- Child feeding practices and maternal report of child sleep patterns [ Time Frame: At 6, 12 and 18 months of age ] [ Designated as safety issue: No ]
- Antibody response to measles vaccination [ Time Frame: At 18 months of age ] [ Designated as safety issue: No ]
- Malaria immunity [ Time Frame: At 6 and 18 months of age ] [ Designated as safety issue: No ]
- Basal salivary cortisol concentration [ Time Frame: At 6, 12 and 18 months of age ] [ Designated as safety issue: No ]
- Cortisol response to acute stress [ Time Frame: At 6 and 18 months of age ] [ Designated as safety issue: No ]
- Achievement of five motor milestones and four other developmental milestones [ Time Frame: From 0 to 18 mo ] [ Designated as safety issue: No ]
- Neurobehavioral development [ Time Frame: At 18 months of age ] [ Designated as safety issue: No ]
- Incidence of serious adverse events [ Time Frame: During pregnancy and 18 months of infant follow-up ] [ Designated as safety issue: Yes ]
- Prevalence of maternal periodontitis [ Time Frame: At one week after delivery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1400 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: IFA group
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
|
Dietary Supplement: IFA
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
|
|
Active Comparator: MMN group
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
|
Dietary Supplement: MMN
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
|
|
Experimental: LNS group
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)
|
Dietary Supplement: LNS
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)
|
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 1536 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.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations| Contact: Per Ashorn, MD, PhD | +358 40 7280 354 | per.ashorn@uta.fi |
| Contact: Kenneth M Maleta, MD, PhD | +265 888 232 202 | kmaleta@medcol.mw |
| Malawi | |
| University of Malawi, College of Medicine | Recruiting |
| Mangochi, Malawi | |
| Contact: Kenneth M Maleta, MBBS, PhD +265 888 232 202 kmaleta@medcol.mw | |
| Contact: John Phuka, MBBS, PhD +265 888 852 668 johnphuka@yahoo.co.uk | |
| Sub-Investigator: Lindsay Allen, PhD | |
| Sub-Investigator: Ulla Ashorn, PhD | |
| Sub-Investigator: Kathryn G Dewey, PhD | |
| Sub-Investigator: Jan Peerson, M.S. | |
| Sub-Investigator: John Phuka, MBBS, PhD | |
| Sub-Investigator: Stephen A Vosti, PhD | |
| Principal Investigator: | Per Ashorn, MD, PhD | University of Tampere Medical School |
More Information
Additional Information:
No publications provided
| Responsible Party: | Per Ashorn, Professor of International Health, University of Tampere |
| ClinicalTrials.gov Identifier: | NCT01239693 History of Changes |
| Other Study ID Numbers: | iLiNS-DYAD-M |
| Study First Received: | November 10, 2010 |
| Last Updated: | June 17, 2012 |
| Health Authority: | Malawi: College of Medicine Research and Ethics Committee |
Keywords provided by University of Tampere:
|
Malnutrition Stunting Growth failure Lipid based nutrient supplement LNS Prevention Malawi |
Sub-Saharan Africa Dietary supplementation Efficacy Pregnancy Infancy Newborn |
Additional relevant MeSH terms:
|
Malnutrition Infant Nutrition Disorders Nutrition Disorders Micronutrients |
Trace Elements Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013