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| Name | Class |
|---|---|
| Shanghai Institute of Planned Parenthood Research | OTHER_GOV |
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This randomized controlled trial with fish oil supplementation to pregnant women conducted in areas of China, which are generally low in fish intake and low income, aims at answering the following primary questions:
The basic design is that of a randomized controlled trial with three groups randomized in ratios of 1:1:1. Two different doses of long chain n-3 fatty acids are tested against zero grams long chain n-3 fatty acids (lc-n3FA). These are provided in similarly looking gelatine capsules with either fish oil, a mixture (1:3) of fish oil and olive oil, or olive oil. Eligible women are randomized at around gestation weeks 16-24 and are asked to take the capsules until they have completed the preterm period (i.e. at 37 full gestation weeks) or until they deliver. Women are asked to complete questionnaires at randomization about diet and other baseline information, and again in gestation week 30 and after delivery. The trial is undertaken at hospitals in the two provinces of Gan-Su and Shaanxi. The three randomization groups will be compared with respect to proportions of preterm delivery. Cox regression will be used to compare the groups with respect to rates of spontaneous deliveries while accounting for elective delivery by regarding these as censoring events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose fish oil | Experimental | Women will be offered 4 capsules per day containing fish oil |
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| Low dose fish oil | Experimental | Women will be offered 4 capsules per day containing mixed fish oil and olive oil |
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| Control | Placebo Comparator | Women will be offered 4 capsules per day containing olive oil |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose fish oil | Dietary Supplement | Four 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Premature birth | Delivery occurring earlier than 259 gestation days | 20 weeks on average, from randomization at gestation weeks 16-24 until on average gestation week 40 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sjurdur F Olsen, Ph.D. | Statens Serum Institut | Study Director |
| Weijin Zhou, Ph.D. | Shanghai Institute of Planned Parenthood Research | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31387119 | Derived | Olsen SF, Halldorsson TI, Li M, Strom M, Mao Y, Che Y, Wang Y, Duan F, Olsen J, Zhou W. Examining the Effect of Fish Oil Supplementation in Chinese Pregnant Women on Gestation Duration and Risk of Preterm Delivery. J Nutr. 2019 Nov 1;149(11):1942-1951. doi: 10.1093/jn/nxz153. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
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| Low dose fish oil | Dietary Supplement | Four 0.72-gram gelatine capsules per day with a mixture of fish oil and olive oil providing 0.5 g/d lc-n3FA |
|
| Olive oil | Dietary Supplement | Four 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA |
|
| D000091642 | Urogenital Diseases |
| D005223 |
| Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |