The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol
Abstract Background Evidence suggests a strong association between nutrition during the first 1000 days (conception to 2 years of life) and cognitive development. Maternal docosahexaenoic acid (DHA) supplementation has been suggested to be linked with cognitive development of their offspring. DHA is...
| Main Authors: | , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-08-01
|
| Series: | BMC Pediatrics |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12887-018-1225-5 |
| _version_ | 1819071791909306368 |
|---|---|
| author | Shweta Khandelwal M. K. Swamy Kamal Patil Dimple Kondal Monica Chaudhry Ruby Gupta Gauri Divan Mahesh Kamate Lakshmy Ramakrishnan Mrutyunjaya B. Bellad Anita Gan Bhalchandra S. Kodkany Reynaldo Martorell K. Srinath Reddy Dorairaj Prabhakaran Usha Ramakrishnan Nikhil Tandon Aryeh D. Stein |
| author_facet | Shweta Khandelwal M. K. Swamy Kamal Patil Dimple Kondal Monica Chaudhry Ruby Gupta Gauri Divan Mahesh Kamate Lakshmy Ramakrishnan Mrutyunjaya B. Bellad Anita Gan Bhalchandra S. Kodkany Reynaldo Martorell K. Srinath Reddy Dorairaj Prabhakaran Usha Ramakrishnan Nikhil Tandon Aryeh D. Stein |
| author_sort | Shweta Khandelwal |
| collection | DOAJ |
| description | Abstract Background Evidence suggests a strong association between nutrition during the first 1000 days (conception to 2 years of life) and cognitive development. Maternal docosahexaenoic acid (DHA) supplementation has been suggested to be linked with cognitive development of their offspring. DHA is a structural component of human brain and retina, and can be derived from marine algae, fatty fish and marine oils. Since Indian diets are largely devoid of such products, plasma DHA levels are low. We are testing the effect of pre- and post-natal DHA maternal supplementation in India on infant motor and mental development, anthropometry and morbidity patterns. Methods DHANI is a double-blinded, parallel group, randomized, placebo controlled trial supplementing 957 pregnant women aged 18–35 years from ≤20 weeks gestation through 6 months postpartum with 400 mg/d algal-derived DHA or placebo. Data on the participant’s socio-demographic profile, anthropometric measurements and dietary intake are being recorded at baseline. The mother-infant dyads are followed through age 12 months. The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII). Secondary outcomes are gestational age, APGAR scores, and infant anthropometry. Biochemical indices (blood and breast-milk) from mother-child dyads are being collected to estimate changes in DHA levels in response to supplementation. All analyses will follow the intent-to-treat principle. Two-sample t test will be used to test unadjusted difference in mean DASII score between placebo and DHA group. Adjusted analyses will be performed using multiple linear regression. Discussion Implications for maternal and child health and nutrition in India: DHANI is the first large pre- and post-natal maternal dietary supplementation trial in India. If the trial finds substantial benefit, it can serve as a learning to scale up the DHA intervention in the country. Trial registration The trial is retrospectively registered at clinicaltrials.gov (NCT01580345, NCT03072277) and ctri.nic.in (CTRI/2013/04/003540, CTRI/2017/08/009296). |
| first_indexed | 2024-12-21T17:27:27Z |
| format | Article |
| id | doaj.art-c31cd7dca3674078a012f3449bf67279 |
| institution | Directory Open Access Journal |
| issn | 1471-2431 |
| language | English |
| last_indexed | 2024-12-21T17:27:27Z |
| publishDate | 2018-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj.art-c31cd7dca3674078a012f3449bf672792022-12-21T18:56:01ZengBMCBMC Pediatrics1471-24312018-08-0118111110.1186/s12887-018-1225-5The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocolShweta Khandelwal0M. K. Swamy1Kamal Patil2Dimple Kondal3Monica Chaudhry4Ruby Gupta5Gauri Divan6Mahesh Kamate7Lakshmy Ramakrishnan8Mrutyunjaya B. Bellad9Anita Gan10Bhalchandra S. Kodkany11Reynaldo Martorell12K. Srinath Reddy13Dorairaj Prabhakaran14Usha Ramakrishnan15Nikhil Tandon16Aryeh D. Stein17Public Health Foundation of IndiaKLEU’s JN Medical CollegeKLEU’s JN Medical CollegePublic Health Foundation of IndiaPublic Health Foundation of IndiaPublic Health Foundation of IndiaSangathChild Development Centre, Prabhakar Kore HospitalAll India Institute of Medical SciencesKLEU’s JN Medical CollegeKLEU’s JN Medical CollegeResearch Foundation, KLE UniversityHubert Department of Global Health, Rollins School of Public Health Emory UniversityPublic Health Foundation of IndiaPublic Health Foundation of IndiaHubert Department of Global Health, Rollins School of Public Health Emory UniversityAll India Institute of Medical SciencesHubert Department of Global Health, Rollins School of Public Health Emory UniversityAbstract Background Evidence suggests a strong association between nutrition during the first 1000 days (conception to 2 years of life) and cognitive development. Maternal docosahexaenoic acid (DHA) supplementation has been suggested to be linked with cognitive development of their offspring. DHA is a structural component of human brain and retina, and can be derived from marine algae, fatty fish and marine oils. Since Indian diets are largely devoid of such products, plasma DHA levels are low. We are testing the effect of pre- and post-natal DHA maternal supplementation in India on infant motor and mental development, anthropometry and morbidity patterns. Methods DHANI is a double-blinded, parallel group, randomized, placebo controlled trial supplementing 957 pregnant women aged 18–35 years from ≤20 weeks gestation through 6 months postpartum with 400 mg/d algal-derived DHA or placebo. Data on the participant’s socio-demographic profile, anthropometric measurements and dietary intake are being recorded at baseline. The mother-infant dyads are followed through age 12 months. The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII). Secondary outcomes are gestational age, APGAR scores, and infant anthropometry. Biochemical indices (blood and breast-milk) from mother-child dyads are being collected to estimate changes in DHA levels in response to supplementation. All analyses will follow the intent-to-treat principle. Two-sample t test will be used to test unadjusted difference in mean DASII score between placebo and DHA group. Adjusted analyses will be performed using multiple linear regression. Discussion Implications for maternal and child health and nutrition in India: DHANI is the first large pre- and post-natal maternal dietary supplementation trial in India. If the trial finds substantial benefit, it can serve as a learning to scale up the DHA intervention in the country. Trial registration The trial is retrospectively registered at clinicaltrials.gov (NCT01580345, NCT03072277) and ctri.nic.in (CTRI/2013/04/003540, CTRI/2017/08/009296).http://link.springer.com/article/10.1186/s12887-018-1225-5Docosahexaenoic acid (DHA)Omega 3 fatty acidsPolyunsaturated fatty acidsn3PUFANeurodevelopmentDevelopment assessment scale for Indian infants (DASII) |
| spellingShingle | Shweta Khandelwal M. K. Swamy Kamal Patil Dimple Kondal Monica Chaudhry Ruby Gupta Gauri Divan Mahesh Kamate Lakshmy Ramakrishnan Mrutyunjaya B. Bellad Anita Gan Bhalchandra S. Kodkany Reynaldo Martorell K. Srinath Reddy Dorairaj Prabhakaran Usha Ramakrishnan Nikhil Tandon Aryeh D. Stein The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol BMC Pediatrics Docosahexaenoic acid (DHA) Omega 3 fatty acids Polyunsaturated fatty acids n3PUFA Neurodevelopment Development assessment scale for Indian infants (DASII) |
| title | The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol |
| title_full | The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol |
| title_fullStr | The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol |
| title_full_unstemmed | The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol |
| title_short | The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol |
| title_sort | impact of docosahexaenoic acid supplementation during pregnancy and lactation on neurodevelopment of the offspring in india dhani trial protocol |
| topic | Docosahexaenoic acid (DHA) Omega 3 fatty acids Polyunsaturated fatty acids n3PUFA Neurodevelopment Development assessment scale for Indian infants (DASII) |
| url | http://link.springer.com/article/10.1186/s12887-018-1225-5 |
| work_keys_str_mv | AT shwetakhandelwal theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT mkswamy theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT kamalpatil theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT dimplekondal theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT monicachaudhry theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT rubygupta theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT gauridivan theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT maheshkamate theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT lakshmyramakrishnan theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT mrutyunjayabbellad theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT anitagan theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT bhalchandraskodkany theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT reynaldomartorell theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT ksrinathreddy theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT dorairajprabhakaran theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT usharamakrishnan theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT nikhiltandon theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT aryehdstein theimpactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT shwetakhandelwal impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT mkswamy impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT kamalpatil impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT dimplekondal impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT monicachaudhry impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT rubygupta impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT gauridivan impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT maheshkamate impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT lakshmyramakrishnan impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT mrutyunjayabbellad impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT anitagan impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT bhalchandraskodkany impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT reynaldomartorell impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT ksrinathreddy impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT dorairajprabhakaran impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT usharamakrishnan impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT nikhiltandon impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol AT aryehdstein impactofdocosahexaenoicacidsupplementationduringpregnancyandlactationonneurodevelopmentoftheoffspringinindiadhanitrialprotocol |