A double blind randomised controlled trial comparing standard dose of iron supplementation for pregnant women with two screen-and-treat approaches using hepcidin as a biomarker for ready and safe to receive iron

AbstractConcerns have been raised about the benefits of Fe-containing supplements on infant birth weight among women with normal/high Hb levels at baseline. Thus far, no clinical trials have examined whether the effects of prenatal Fe-containing supplements on birth weight vary by maternal Hb levels. We compared the effects of Fe–folic acid (IFA) or multiple micronutrients (MMN) with folic acid (FA) supplements on birth weight among pregnant women with mild/no anaemia or high Hb levels. A double-blind randomised controlled trial was conducted in 2006–2009. In total, 18 775 pregnant women with mild/no anaemia (<100 g/l) were enrolled from five counties in north China. During the period from before 20 weeks of gestation to delivery, the women randomly received a daily supplement containing the following: (1) FA (400 μg); (2) IFA (FA, 400 μg; Fe, 30 mg); or (3) MMN (FA, Fe and thirteen additional vitamins and minerals). Birth weight was measured within the 1st hour of birth. Maternal Hb concentration was determined at enrolment. Among women with normal (≤132 g/l) or high (133–145 g/l) baseline Hb levels, IFA or MMN supplementation had no effect on birth weight. Among women with very high (>145 g/l) baseline Hb levels, IFA and MMN supplements increased birth weight by 91·44 (95 % CI 3·37, 179·51) g and 107·63 (95 % CI 21·98, 193·28) g (P<0·05), respectively, compared with the FA group. No differences were found between the IFA and the MMN group, regardless of maternal Hb concentration. In conclusion, the effects of Fe-containing supplements on birth weight depended on baseline Hb concentrations. The Fe-containing supplements improved birth weight in women with very high Hb levels before 20 weeks of gestation.

Download Full-text

Intermittent malaria treatment and iron supplementation for the control of malaria and anaemia in infants in the Forest Belt of rural Ghana: a double-blind randomised controlled trial

http://isrctn.org/> ◽

10.1186/isrctn85737357 ◽

2012 ◽

Author(s):

Melba Gomes

Keyword(s):

Randomised Controlled Trial ◽

Iron Supplementation ◽

Controlled Trial ◽

Malaria Treatment ◽

Forest Belt ◽

Double Blind ◽

Rural Ghana ◽

Randomised Controlled

Download Full-text

The effect of zinc supplementation on pregnancy outcomes: a double-blind, randomised controlled trial, Egypt

British Journal Of Nutrition ◽

10.1017/s000711451500166x ◽

2015 ◽

Vol 114 (2) ◽

pp. 274-285 ◽

Cited By ~ 10

Author(s):

Samia A. Nossier ◽

Noha E. Naeim ◽

Nawal A. El-Sayed ◽

Azza A. Abu Zeid

Keyword(s):

Randomised Controlled Trial ◽

Pregnant Women ◽

Pregnancy Outcomes ◽

Controlled Trial ◽

Neonatal Morbidity ◽

Control Group ◽

Double Blind ◽

Serum Zn ◽

Randomised Controlled ◽

Low Serum

The present randomised controlled trial (RCT) was conducted to evaluate the effect of two regimens of Zn supplementation on pregnancy outcomes in Alexandria, Egypt. Healthy pregnant women aged 20–45 years and having low serum Zn level below the estimated median for the gestational age were eligible to participate in the trial. Of 1055 pregnant women assessed for the eligibility of low serum Zn level, 675 were eligible. These women were randomly assigned to one of the three groups: the Zn alone group (n 225) received a daily dose of 30 mg ZnSO4, the combined group (n 227) received 30 mg ZnSO4 plus multivitamins (B1, B6, D3, C and E) and the control group (n 223) received placebo (270 mg lactose). They were followed up from the time of recruitment till 1 week after delivery. Overall, there was no detectable difference in the mean birth weight between the three groups (mean 2929·12 (sd 330·28), 2922·22 (sd 324·05) and 2938·48 (sd 317·39) g for the placebo, Zn and Zn plus multivitamin groups, respectively, P= 0·88). Both the single and the combined Zn supplements were almost equally effective in reducing second- and third-stage complications (relative risk (RR) 0·43, 95 % CI 0·31, 0·60 for the Zn group and RR 0·54, 95 % CI 0·40, 0·73 for the combined group). Stillbirth and preterm delivery were significantly lower among the two supplemented groups than the placebo group (P= 0·001). Early neonatal morbidity was also significantly lower in the supplemented groups (RR 0·23, 95 % CI 0·15, 0·35 for the Zn group and RR 0·25, 95 % CI 0·16, 0·37 for the combined group). Collectively, Zn supplementation was effective in reducing pregnancy complications and early neonatal infection among the Zn-deficient women of the present trial.

Download Full-text

Efficacy and safety of hepcidin-based screen-and-treat approaches using two different doses versus a standard universal approach of iron supplementation in young children in rural Gambia: a double-blind randomised controlled trial

BMC Pediatrics ◽

10.1186/s12887-016-0689-4 ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 14

Author(s):

Rita Wegmüller ◽

Amat Bah ◽

Lindsay Kendall ◽

Morgan M. Goheen ◽

Sarah Mulwa ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Young Children ◽

Iron Supplementation ◽

Controlled Trial ◽

Efficacy And Safety ◽

Double Blind ◽

Universal Approach ◽

Randomised Controlled ◽

Different Doses

Download Full-text

Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-034987 ◽

2020 ◽

Vol 10 (5) ◽

pp. e034987

Author(s):

Jitender Nagpal ◽

Manu Raj Mathur ◽

Swapnil Rawat ◽

Deepti Nagrath ◽

Charlotte Lee ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Post Partum ◽

Controlled Trial ◽

Clinical Care ◽

First Trimester ◽

Clinical Trial Registry ◽

Double Blind ◽

Study Results ◽

Randomised Controlled ◽

To Receive

IntroductionVitamin B12 deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B12 deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.Methods and analysisThis double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring’s neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant’s biochemical B12 status at age 9 months and maternal biochemical B12 status in the first and third trimesters. Maternal biochemical B12 status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.Ethical considerations and disseminationThe study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits.Trial registration numberCTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov)

Download Full-text