Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00168688
Status:
COMPLETED
Last Update Posted:
2013-11-18
First Post:
2005-09-13
Brief Title:
Prenatal Multi-micronutrient Supplementation and Pregnancy Outcome
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
The Effects of Prenatal Multi-micronutrient Supplements on Pregnancy Outcome Peri- and Neonatal Mortality on Maternal and Infant Nutritional Status A Randomised Controlled Trial Among Women in Guinea-Bissau
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prenatal maternal micronutrient supplementation has been suggested as a means to reduce the proportion of low birth weight babies in low-income countries The effects of prenatal multi-micronutrient supplements on birth weight and perinatal mortality were studied in a randomised controlled trial among 2100 pregnant women in Guinea-Bissau Women up to 37 weeks pregnant were individually randomised to daily supplements until delivery of A Iron folic acid or multi-micronutrients in B One or C Two recommended dietary allowances Secondary outcomes were infant growth and maternal haemoglobin eight weeks after delivery
Detailed Description:
Prenatal maternal micronutrient supplementation has been suggested as a means to reduce the proportion of low birth weight babies in low-income countries The effects of prenatal multi-micronutrient supplements on birth weight and perinatal mortality were studied in a randomised controlled trial among 2100 pregnant women in Guinea-Bissau Women up to 37 weeks pregnant were individually randomised to daily supplements until delivery of identically looking tablets containing 1 Iron 60 mg folate 400 µg 2 One recommended dietary allowance RDA of 5 minerals and 10 vitamins including iron 30 mg and folate 400 µg or 3 Two RDAs of 5 minerals and 10 vitamins including iron 30 mg and folate 800 µg Supplements were provided in known excess at fortnightly home visits until delivery Compliance was assessed by tablet count
Women were interviewed about age civil status obstetric history and socio-economic status at enrolment Maternal anthropometry was measured at enrolment at delivery and eight weeks after delivery Maternal malaria parasitaemia and haemoglobin were measured at enrolment and eight weeks after delivery Maternal status of a wide range of micronutrients was assessed at enrolment and eight weeks after delivery in a sub-cohort of 600 women Further survival of the infants will be followed until 3 years of age within the routines of the Bandim Health Project surveillance system
Women were provided impregnated bed nets and weekly malaria prophylaxis until delivery Women with high malaria parasitaemia at enrolment were in addition given a full treatment at enrolment
Sample size considerations A sample size of 638 women in each treatment group will be required to detect a reduction in perinatal mortality from 9 to 5 or less in a treatment group using 80 power and a 5 significance level With an expected loss to follow up of 10 2100 women are required With a sample size of 2100 the study will be able to detect at least 75 g difference ie a 25 change in birth weight
Women were interviewed about age civil status obstetric history and socio-economic status at enrolment Maternal anthropometry was measured at enrolment at delivery and eight weeks after delivery Maternal malaria parasitaemia and haemoglobin were measured at enrolment and eight weeks after delivery Maternal status of a wide range of micronutrients was assessed at enrolment and eight weeks after delivery in a sub-cohort of 600 women Further survival of the infants will be followed until 3 years of age within the routines of the Bandim Health Project surveillance system
Women were provided impregnated bed nets and weekly malaria prophylaxis until delivery Women with high malaria parasitaemia at enrolment were in addition given a full treatment at enrolment
Sample size considerations A sample size of 638 women in each treatment group will be required to detect a reduction in perinatal mortality from 9 to 5 or less in a treatment group using 80 power and a 5 significance level With an expected loss to follow up of 10 2100 women are required With a sample size of 2100 the study will be able to detect at least 75 g difference ie a 25 change in birth weight
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None