Methods
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Study design: Randomized controlled trial |
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Unit of randomization: Individually randomised |
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Type of study: Food Distribution Program |
Participants
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Location/setting: Farming communities of West Kiang region, Gambia |
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Population: 15 000 |
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Sample size: 620 |
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Drop outs/withdrawal: The exclusions were due to missing birth weight data (N = 129) |
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Socio‐demographics
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Median (SD) age:
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Intervention: 29.8 |
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Control: 30 |
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Age range: 18–45 years |
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Occupation: Farming |
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Race: Not specified |
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Education: Not specified |
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Family income: Not specified |
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Inclusion criteria:
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Women confirmed as being between 10 and 20 weeks pregnant by ultrasound |
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Nonpregnant women of reproductive age (18–45 years) |
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Exclusion criteria:
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Women who were |
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(i)
currently pregnant (beyond 20 weeks on ultrasound assessment),
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(ii)
currently enrolled in another MRC study,
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(iii)
severely anaemic at booking (haemoglobin (Hb) <7 g/dl), or
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(iv)
report the onset of menopause were excluded from entry into the trial
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Interventions
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Intervention (sample size):
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Protein Energy (PE) provided with 746 kcal/day of energy from protein and lipids. It was provided to pregnant women between 10‐20th week of gestation. LNS was distributed on a weekly basis to participating women. LNS were supplied in jars, with a single (daily) dose per jar. It was provided through field workers and midwives (n = 151) |
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Control (sample size):
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FeFol (iron 60 mg/day and folic acid 400 μg/day) was given as a prenatal care. It was provided to pregnant women between 10‐20th week of gestation. It was provided through field workers and midwives. Supplementation commenced the following week, receiving daily tablet supplements. Both supplement types (tablets and LNS) were distributed on a weekly basis to participating women. Women were supplied with 14 tablets per week in individual bottles and advised to take two tablets per day, preferably with food (n = 146) |
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Concomitant interventions: Not specified |
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Training:
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Prior to the start of the study, two sonographers were trained in fetal biometry |
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Follow‐up:
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Subsequent clinic visits were made at 20 and 30 weeks of gestation, and a home visit performed within 72 h of birth |
Outcomes
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Primary outcomes: None |
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Secondary outcomes:
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Low birthweight |
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Preterm birth |
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Small for gestational age |
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Timing of outcome assessment: At birth |
Notes
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Study start date: January 2010 |
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Study end date: February 2014 |
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Time period: 4 years |
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Study country: Gambia |
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Study limitations:
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This was a post‐hoc analysis with a sample size that was not powered on the outcomes or for the subgroup analyses. Other limitations include not having a maternal weight measure at the very end of gestation, which would have allowed the author to quantify weight gain throughout the final trimester, and not necessarily being able to generalize results to other populations |
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Funding source:
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This trial was supported by the UK Medical Research Council (MRC) (MC‐A760‐5QX00) and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement. WJ and SEM are funded by the UK MRC programme MC_UP_1005/1 |
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Conflict of interest: None |