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The purpose of this study is to learn if participants in the ADORE study (NCT02626299), who took a DHA supplement during pregnancy, see favorable body fat in their infants from birth to 24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADORE- 200 mg/day | Participants enrolled in the ADORE study that were randomly assigned to the 200 mg/day group that consented to participate in ADORE-GAINS. | ||
| ADORE - 1000 mg/day | Participants enrolled in the ADORE study that were randomly assigned to the 1000 mg/day group that consented to participate in ADORE-GAINS. |
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| Measure | Description | Time Frame |
|---|---|---|
| Infant Fat Mass (FM) | Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central Fat Mass | Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG | 24 months |
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Participants for this study are invited from the parent study, ADORE. Eligibility listed reflects criteria for the ADORE study.
Inclusion Criteria:
Exclusion Criteria:
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Participants are invited from those already participating in the parent study, ADORE.
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| Name | Affiliation | Role |
|---|---|---|
| Holly Hull, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38948108 | Derived | Hull HR, Brown A, Gajewski B, Sullivan DK, Carlson SE. The Effect of Prenatal Docosahexaenoic Acid Supplementation on Offspring Fat Mass and Distribution at 24 Months Old. Curr Dev Nutr. 2024 May 11;8(6):103771. doi: 10.1016/j.cdnut.2024.103771. eCollection 2024 Jun. | |
| 37406769 | Derived | Hull HR, Gajewski BJ, Sullivan DK, Carson SE. Growth and adiposity in newborns study (GAINS): The influence of prenatal DHA supplementation protocol. Contemp Clin Trials. 2023 Sep;132:107279. doi: 10.1016/j.cct.2023.107279. Epub 2023 Jul 3. |
| Label | URL |
|---|---|
| ADORE Clinicaltrials.gov Record - Parent Study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 200 MG/DAY | Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study. |
| FG001 | 1000 MG/DAY | Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADORE- 200 mg/Day | Participants enrolled in the ADORE study that were randomly assigned to the 200 mg/day group that consented to participate in ADORE-GAINS. 200 mg/day Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. |
| BG001 | ADORE - 1000 mg/Day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infant Fat Mass (FM) | Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG | Of the participants that completed the 24 month visit, many refused or were uncooperative during the DXA scan. And even a higher percentage were deemed unusable scans due to infant movement. | Posted | Mean | 95% Confidence Interval | g | 24 months |
|
Collected for the duration of study visits, 24 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 200 MG/DAY | Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Holly Hull | University of Kansas Medical Center | 9135881000 | hhull@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2020 | Nov 30, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2022 | Nov 30, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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Participants enrolled in the ADORE study that were randomly assigned to the 1000 mg/day group that consented to participate in ADORE-GAINS. 1000 mg/day Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| DHA mean % of RBC Total Fatty Acids | Mean | Standard Deviation | percent of total fatty acids in RBC |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Central Fat Mass | Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG | Of the participants that completed the 24 month visit, many refused or were uncooperative during the DXA scan. And even a higher percentage were deemed unusable scans due to infant movement. | Posted | Mean | 95% Confidence Interval | g | 24 months |
|
|
|
| 0 |
| 124 |
| 0 |
| 124 |
| 0 |
| 124 |
| EG001 | 1000 MG/DAY | Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study. | 0 | 126 | 0 | 126 | 0 | 126 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |