scholarly journals A Randomized Controlled Trial of Daily and Weekly Iron Supplementations for Improving Iron Status in the Infants

2021 ◽  
Author(s):  
Nalinee Pattrakornkul ◽  
Parichaya Ngamcherdtrakul ◽  
Warawut Kriangburapa ◽  
Siriporn Tangjaturonrasme ◽  
Ramorn Yampratoom
Keyword(s):  
Randomized Controlled Trial ◽  
Iron Deficiency ◽  
Iron Supplementation ◽  
Iron Status ◽  
Controlled Trial ◽  
Daily Group ◽  
Randomized Controlled ◽  
The Mean ◽  
Mean Differences ◽  
Weekly Group

Abstract Background: Iron deficiency anemia screening and iron supplementation in infants aged 6-12 months are recommended in the Guideline in Child Health Supervision. This study aims to evaluate the effectiveness of weekly iron supplementation compared with daily supplementation in improving the iron status in infants.Methods: A single-blind randomized controlled trial was conducted in infants aged 6 months visiting the Well Child Clinic between May 2019 and November 2020 at Burapha University Hospital, Chonburi, Thailand. The intervention consisted of either daily or weekly iron supplementation combined with iron-rich complementary food promotion for six months. The outcomes were the differences of serum ferritin and hematological variables before and after being iron supplemented. Results: Sixty-nine six-month-old healthy infants were randomized to receive either 10 mg Fe/day (daily group) or 30 mg Fe/week (weekly group). Forty-five infants (daily group; n = 24 and weekly group; n = 21) completed the intervention. After the six-month period of iron supplementation, the mean differences of serum ferritin in the daily and the weekly group were 8.78±37.21 and -13.05 ±17.53 ng/mL, respectively (95%CI: 4.54, 39.12; P=0.015). The mean differences of hemoglobin in the daily and the weekly group were 0.58±0.82 and 0.08±0.59 g/dL, respectively (95%CI: 0.06, 0.93; P=0.026). Daily supplementation could prevent iron deficiency more than weekly supplementation significantly (P=0.029), particularly in the exclusive breastfeeding subgroup (P=0.032).Conclusions: Daily iron supplementation is more effective than weekly iron supplementation in improving iron status and hemoglobin level in infants, especially in the exclusively breast-feds.Trial registration: TCTR20191107001, November 7th, 2019. Retrospectively registered, http://www.thaiclinicaltrials.org

Daily and Weekly Iron Supplementations to Improve Iron Status in Infants: A Randomized Controlled Trial

2021 ◽  
Vol 104 (9) ◽  
pp. 1511-1518
Keyword(s):  
Randomized Controlled Trial ◽  
Iron Deficiency ◽  
Serum Ferritin ◽  
Iron Supplementation ◽  
Iron Status ◽  
Controlled Trial ◽  
Deficiency Anemia ◽  
Daily Group ◽  
Randomized Controlled ◽  
Weekly Group

Background: Iron deficiency anemia screening and iron supplementation in infants aged 6 to12 months are recommended in the Guideline in Child Health Supervision. Objective: To evaluate the effectiveness of weekly iron supplementation compared with daily supplementation in improving the iron status in infants. Materials and Methods: A single-blind randomized controlled trial was conducted in infants aged 6 months visiting the Well Child Clinic between May 2019 and November 2020 at Burapha University Hospital, Chonburi, Thailand. The intervention consisted of either daily or weekly iron supplementation combined with iron-rich complementary food promotion for six months. The outcomes were the differences of serum ferritin and hematological variables before and after being iron supplemented. Results: Sixty-nine of the six-month-old healthy infants were randomized to receive either 10 mg Fe/day as the daily group or 30 mg Fe/week as the weekly group. Forty-five infants with 24 in the daily group and 21 in the weekly group completed the intervention. After the six-month period of iron supplementation, the average differences of serum ferritin in the daily and the weekly group were 10.85 (–13.19, 34.49) and –9.31 (–23.86, –2.30) ng/mL, respectively (p=0.012). The average differences of hemoglobin in the daily and the weekly group were 0.58±0.82 and 0.08±0.59 g/dL, respectively (95% CI 0.06 to 0.93; p=0.026). Conclusion: Daily iron supplementation of 10 mg/day is more effective than 30 mg weekly iron supplementation in improving iron status and hemoglobin level in the Thai infants. Keywords: Anemia; Ferritin; Infants; Iron deficiency; Iron supplementation

scholarly journals Effects of Vitamin A Supplementation on Iron Status Indices and Iron Deficiency Anaemia: A Randomized Controlled Trial

Nutrients ◽  
2013 ◽  
Vol 6 (1) ◽  
pp. 190-206 ◽  
Author(s):  
Hesham Al-Mekhlafi ◽  
Ebtesam Al-Zabedi ◽  
Mohamed Al-Maktari ◽  
Wahib Atroosh ◽  
Ahmed Al-Delaimy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Iron Deficiency ◽  
Vitamin A ◽  
Iron Deficiency Anaemia ◽  
Iron Status ◽  
Controlled Trial ◽  
Vitamin A Supplementation ◽  
Deficiency Anaemia ◽  
Randomized Controlled

scholarly journals Effectiveness of a “Spring Pillow” Versus Education in Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

2019 ◽  
Vol 99 (9) ◽  
pp. 1177-1188 ◽  
Author(s):  
Carla Vanti ◽  
Federico Banchelli ◽  
Claudia Marino ◽  
Andrea Puccetti ◽  
Andrew A Guccione ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neck Pain ◽  
Educational Intervention ◽  
Controlled Trial ◽  
University Hospital ◽  
Thoracic Pain ◽  
Randomized Controlled ◽  
Different Types ◽  
The Mean ◽  
Mean Differences

Abstract Background Different types of pillows have been proposed for neck pain, but no previous randomized controlled trial has investigated the effectiveness of a “spring pillow” for adults with chronic nonspecific neck pain. Objective We evaluated the effectiveness of using a pillow made from viscoelastic polyurethane and 60 independent springs compared with an educational intervention in individuals with chronic nonspecific neck pain. Design This was a randomized controlled trial with crossover study design. Setting The setting was the Occupational Medicine Unit, University Hospital, Bologna (Italy). Participants We recruited 70 adults with chronic nonspecific neck pain, of whom 64 completed the trial. Intervention Participants were randomly assigned to 2 groups. One group used the spring pillow for 4 weeks, and the other group followed educational advice for 4 weeks while continuing to use their own pillows. After 4 weeks of treatment and 4 weeks of washout, groups were crossed over. Pain perceived in the neck, thoracic, and shoulder areas and headache were the primary outcome measures. In addition, disability, sleep quality, subjective improvement, and pillow comfort were assessed. Measures were captured at pretreatment, after 4 weeks, after the 4-week washout period, and 4 weeks after crossover. The mean differences (MD) in outcomes between groups were assessed. Results Treatment with the spring pillow appeared to reduce neck pain (MD = −8.7; 95% confidence interval [CI] = −14.7 to −2.6), thoracic pain (MD = −8.4; 95% CI = −15.2 to −1.5), and headache (MD = −16.0; 95% CI = −23.2 to −8.7). Reductions in shoulder pain were not statistically significant between groups (MD = −6.9; 95% CI = −14.1–0.3). Neither the crossover sequence nor the period (first vs second intervention administration) significantly affected the results. Limitations Education may not have been the best comparator for the spring pillow; drug consumption, actual pillow use, and the implementation of the educational suggestions as prescribed were not controlled. Conclusions Use of the spring pillow in this study was more effective than an educational intervention for improving cervical, thoracic, and head pain. Whether a spring pillow is more effective than other ergonomic pillows remains to be tested.

The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Asieh Mehdipour ◽  
Parvin Abedi ◽  
Somayeh Ansari ◽  
Maryam Dastoorpoor
Keyword(s):  
Randomized Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Moderate Depression ◽  
Before And After ◽  
The Mean ◽  
And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

Intravenous versus Oral iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial

2021 ◽  
Author(s):  
Adam K. Lewkowitz ◽  
Molly J. Stout ◽  
Emily Cooke ◽  
Seon C. Deoni ◽  
Viren D'Sa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Randomized Controlled ◽  
Iv Iron ◽  
Severe Adverse Reactions

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points

scholarly journals Results Are Similar Two Years After Acute or Delayed Anterior Cruciate Ligament Reconstruction. A Randomized Controlled Trial

2017 ◽  
Vol 5 (5_suppl5) ◽  
pp. 2325967117S0017
Author(s):  
Karl Eriksson ◽  
Christoffer von Essen ◽  
Björn Barenius
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Endpoint ◽  
Pivot Shift ◽  
Controlled Trial ◽  
Acl Injury ◽  
Activity Level ◽  
Randomized Controlled ◽  
Delayed Group ◽  
The Mean

Objectives: Acute ACLR has been avoided since the 1990’s due to reports of postoperative stiffness. But are these risks still valid with modern arthroscopic techniques? The aim of this randomized controlled trial was to assess the impact of the time between injury and reconstruction on the outcome after ACLR. Our hypothesis was that acute ACLR with semitendinosus graft can be performed safely. Methods: The primary endpoint was ROM at three months after surgery. A power calculation revealed the need for 64 patients to detect a ROM difference of 5 degrees between the groups (5% significance level). 70 patients with a high recreational activity level (Tegner ≥6) who presented with an acute ACL injury were randomized to an acute reconstruction within 8 days from the injury or delayed reconstruction (after normalized ROM) 6-10 weeks after the injury. Fixation was with Endobutton in femur and a metallic interference screw in tibia. The rehabilitation was performed at the same physiotherapy center for all patients. Follow up assessment was performed by a physiotherapist not involved with the rehabilitation. The follow up at 24 months included ROM, Lachman, instrumented laxity with Rolimeter, pivot shift, one leg hop index, Biodex, IKDC, KOOS, Lysholm and Tegner Activity level, and a VAS question regarding knee function and the knee function’s effect on activity level. Results: Seventy percent of the patients were males, mean age at the time of surgery was 27 years (18 -41) and the median pre-injury Tegner level was 9 (6-10) with no differences between the groups. 64 (91%) patients were assessed at three months with no difference according to the primary endpoint. Median Tegner level was restored to pre-injury levels in both groups after one year, and did not change between one and two years. 63 (90%) patients were available for the 2-year follow up. There was one graft rupture and one contralateral ACL injury in both groups. There was additional surgery in 15% of the acute patients and in 31% in the delayed (n.s.). The mean instrumented laxity was 1.8 mm in the acute and 2.0 in the delayed group. There were no positive pivot shift in the acute group and 6 patients with grade 1 or not possible to perform in the delayed group (p=0.039). IKDC revealed no significant differences between the groups. Lysholm score was 87 in both groups. KOOS values showed no significant difference between the groups. VAS response to the question “How is your knee working on a scale from 0-100? (100 = best)” was 81 in the acute and 71 in the delayed group (p=0.1) and “How does your knee affect your activity level? (100 = no affection)” the mean score was 75 in the acute and 67 in the delayed group (p=0.3). Functional strength (one leg hop index >90%) was 85% in the acute and 67% in the delayed group (n.s). Conclusion: We found no increased risk of arthrofibrosis after acute ACLR. Good results can be achieved at two years regardless of ROM and swelling in the acute stage.

scholarly journals Randomized Controlled Trial of Tailored Music Listening Intervention for Sleep in Dementia

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 215-215
Author(s):  
Darina Petrovsky ◽  
Shana Roan ◽  
Nalaka Gooneratne ◽  
Joke Bradt ◽  
Laura Gitlin ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
African American ◽  
Controlled Trial ◽  
Sleep Disruption ◽  
Music Listening ◽  
Music Intervention ◽  
Clinical Dementia Rating ◽  
Randomized Controlled ◽  
The Mean

Abstract Sleep disruption in older adults living with Alzheimer’s disease and related dementias (ADRD) is debilitating and contributes to increased institutionalization, reduced cognitive function, and accelerated disease progression. Given the potential harmful effects of pharmacologic treatment, non-pharmacologic approaches, such as music, may provide a safer alternative to improve sleep quality in this vulnerable population. No empirically validated music protocol exists to address sleep disruption in older adults with ADRD living at home. Therefore, the specific aims of this wait-list randomized controlled trial were to examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of a tailored music intervention in home-dwelling older adults with ADRD with sleep disruption and their caregivers. This presentation focuses on baseline characteristics of dyads, which included persons with ADRD and their caregivers who have completed the clinical trial so far (N=28). The mean age of persons with ADRD was 71.6 (SD: 7.6). The mean age of caregivers was 58.7 (SD: 16.7). Sixty-eight percent (n=19) of persons with ADRD were female. Similarly, the majority of caregivers were female (n=20, 71.4%). Seventy-four percent of persons with ADRD scored 0.5 on the Clinical Dementia Rating instrument, indicative of very mild dementia. The majority of dyads identified themselves as non-Hispanic (&gt;92%). Seventy-nine percent of persons with ADRD identified themselves as Black or African-American (n=22, 79%), while 82.1% of caregivers identified themselves as Black or African American. Preliminary analysis of qualitative data indicates high acceptability of the intervention. Results from this research study will inform a future efficacy trial.

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