Combination Interventions for Anemia

Overseen By Sahar Sarfaraz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1368 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores various evidence-based interventions to assess their impact on the safety and efficiency of treating anemia, a condition characterized by insufficient healthy red blood cells to carry adequate oxygen throughout the body. The study includes four groups, each experiencing different durations with and without the intervention to determine the most effective approach. The goal is to understand how these treatments can be optimally used in real-world settings by examining factors like cost and ease of implementation. This trial may suit adults recently diagnosed with significant anemia, indicated by lower-than-normal hemoglobin levels, who visit certain clinics in Texas. As an unphased trial, it offers a unique opportunity to contribute to understanding anemia treatment in practical settings.

What prior data suggests that these evidence-based interventions are safe?

Research has shown that treatments for anemia are generally safe and well-tolerated. For example, one study found that a combination of strategies to prevent and treat anemia was both practical and well-received by participants. Another study demonstrated that taking iron supplements, either alone or with folic acid, significantly reduces the risk of anemia and iron deficiency without major side effects. Additionally, oral iron supplements, often recommended for iron deficiency, are considered safe and effective.

These findings suggest that while the effectiveness of treatments can vary, their safety is well-established. However, the quality of studies can differ, and individual experiences may vary. Prospective trial participants should discuss specific health needs with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for anemia because they combine evidence-based strategies to address the condition more comprehensively. Unlike standard treatments like iron supplements and erythropoiesis-stimulating agents that focus on boosting iron levels or stimulating red blood cell production, these interventions aim to integrate multiple approaches over different timelines to maximize effectiveness. By testing various durations of control and intervention phases across multiple clinics, researchers hope to discover the most effective combination and timing for treating anemia, potentially offering more personalized and efficient care options in the future.

What evidence suggests that this trial's treatments could be effective for anemia?

This trial will evaluate combination interventions for anemia, including specialist consultations and evidence-based methods. Research has shown that proven treatments for anemia can be effective. Specifically, studies indicate that vitamin A and various nutrient supplements, especially for pregnant women, can help prevent anemia. Digital health tools have successfully supported adherence to iron supplement routines and increased hemoglobin levels. Collaboration across different sectors is also crucial for effective anemia management. These methods are not only effective but also affordable, making them promising options for reducing anemia worldwide. ^{1 5 6 7 8}

Who Is on the Research Team?

Eric Thomas, MD, MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults with new, significant anemia or reduced kidney function (eGFR <60 ml/min/1.73m2) seen at University of Texas Physicians clinics. It's not suitable for those who don't meet these specific blood and kidney health criteria.

Inclusion Criteria

I have new anemia or my kidney function is lower than normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

Clinics are in a control phase before the intervention is implemented

6-24 months

Intervention

Implementation of evidence-based interventions to improve diagnostic safety and efficiency

6-24 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

1-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Consultation with a Specialist
• Evidence-Based Interventions

Trial Overview The study tests whether usual care combined with specialist consultations improves patient safety and efficiency in diagnosing primary care conditions like anemia and reduced kidney function.

How Is the Trial Designed?

Group I: Step 4 (4 clinics) - 24 months control followed by 6 months of intervention Experimental Treatment 2 Interventions

Group II: Step 3 (3 clinics) - 18 months control followed by 12 months of intervention Experimental Treatment 2 Interventions

Group III: Step 2 (3 clinics) - 12 months control followed by 18 months of intervention Experimental Treatment 2 Interventions

Group IV: Step 1 (3 clinics) - 6 months control followed by 24 months of intervention Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10876383/

Review of intervention products for use in the prevention ... Promising interventions to prevent anemia include vitamin A supplementation, multiple micronutrient supplementation for pregnant women, small-quantity lipid- ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352302625001681

Cost-effective targets for anaemia reduction in 191 countries Our results indicate that an ambitious, achievable, and cost-effective global target for anaemia reduction in women aged 15–49 years by 2030 is ...

3. journals.plos.org journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0004392

The cost-effectiveness of interventions used for the screening ... We conducted a systematic review to identify all studies evaluating the cost-effectiveness of managing anaemia in pregnancy.

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1375622/full

Digital versus non-digital health interventions to improve ... Digital health interventions were effective at improving adherence to oral iron supplementation and hemoglobin levels in pregnant women.

5. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15002

Integrating and coordinating programs for the management of ... Effective anemia programming, therefore, requires evidence-based, data-driven, contextualized multisectoral strategies, with coordinated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7888630/

Evidence-based interventions implemented in low-and middle ... The vast majority of people are not receiving evidence-based interventions (EBIs) to reduce SCD-related adverse outcomes and mortality.

7. sciencedirect.com sciencedirect.com/org/science/article/pii/S2563631625001293

Review Effects of Interventions for the Prevention and ... Although the overall quality of studies was moderate, the interventions showed varied effectiveness in managing and preventing maternal anemia.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832015

Practical Anemia Bundle and Hemoglobin Recovery in ... This randomized clinical trial found that a multifaceted anemia prevention and treatment bundle was feasible, was well tolerated, and improved ...