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NCT02558725
Iron Supplementation During Pregnancy - One Versus Two Ferrous Sulfate Capsules for Iron Deficient Pregnant Women
NA trial testing two capsules of aktiferrin F in Pregnancy Complications, Hematologic in 100 participants. Status unknown.
1 February 2016
Quick facts
| Lead sponsor | Assuta Hospital Systems |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 April 2015 |
| Primary completion | 1 February 2016 |
| Estimated completion | 1 February 2016 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- two capsules of aktiferrin F — full drug profile →
Conditions studied
- Pregnancy Complications, Hematologic — all drugs for Pregnancy Complications, Hematologic →
Sponsor
Assuta Hospital Systems
Who can join
Adults 18 to 42, female only, with Pregnancy Complications, Hematologic. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
mean hemoglobin level
Time frame: at 35 weeks gestation
Sponsor's own description
Since normal pregnancies are associated with dilutional anemia, due to a greater increase in plasma volume with a smaller increase in RBC mass, it is important to properly diagnose IDA according to the levels of serum ferritin. Previous studies examining the optimal iron dose have shown that adjustment of iron supplementation according to serum ferritin levels in early pregnancy could be beneficial. Nonetheless, there is no consensus regarding the appropriate dose of iron during pregnancy, its dose-response curve and its effect on serum ferritin levels. In this trial the investigators sought to assess the efficacy of doubling the daily iron supplement dose in pregnant women with IDA.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02558725
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02558725 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assuta Hospital Systems
- Last refreshed: 28 December 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02558725.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing